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Guideline:

Evidence-based care guideline for cytomegalovirus prophylaxis following solid organ transplants

National Guideline Clearinghouse (NGC). Guideline summary: Evidence-based care guideline for cytomegalovirus prophylaxis following solid organ transplants In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): cited 2001 Jun 7 (revised 2007 July 6). Available: http://www.guideline.gov.


Bibliographic Source(s)

  • Cincinnati Children's Hospital Medical Center. Evidence-based care guideline for cytomegalovirus prophylaxis following solid organ transplants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2007 Jul 6. 15 p. [68 references]

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children's Hospital Medical Center. Evidence based clinical practice guideline for cytomegalovirus prophylaxis following solid organ blood and marrow transplants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2001 Jun 7. 16 p. [145 references]

Guideline Category

Evaluation
Prevention
Risk Assessment

Intended Users

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

Guideline Objective(s)

To provide scientifically based recommendations for preventing or decreasing the incidence of cytomegalovirus (CMV) infection and cytomegalovirus disease

Target Population

These guidelines are intended for use in the following types of transplant patients of all ages:

  • Patients undergoing primary infection prophylaxis following solid organ transplant
  • Patients treated for graft rejection or graft versus host disease (GVHD) following transplantation

These guidelines are not intended for use in the following:

  • Patients with cytomegalovirus (CMV) disease
  • Patients receiving experimental CMV vaccine
  • Non-transplant patients who are immunosuppressed

Interventions and Practices Considered

Evaluation/Risk Assessment for All Transplants

  1. Testing pre-transplant cytomegalovirus (CMV) status of donors and recipients to stratify risk
  2. Clinical assessment and treatment for conditions that may indicate risk for primary induction or reactivation of CMV disease
  3. Quantitative polymerase chain reaction (PCR)

Solid Organ Transplants – Prophylactic Approach

  1. Assessing patients regularly for evidence of CMV disease by clinical examination
  2. Prophylactic therapy
    • Intravenous ganciclovir followed by oral ganciclovir
    • Intravenous ganciclovir in combination with CMV hyperimmune globulin
    • CMV hyperimmune globulin alone
    • Intravenous ganciclovir alone
    • Induction with oral valganciclovir (considered as an alternative in kidney recipients)

Major Outcomes Considered

  • Sensitivity and positive predictive value of cytomegalovirus (CMV) assays
  • Incidence of cytomegalovirus infection following prophylactic therapy
  • Adverse effects of prophylactic therapy

Methods Used to Collect/Select Evidence

Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

To select evidence for critical appraisal by the group for the update of this guideline the Medline EmBase and the Cochrane databases were searched. Evidence from 2000 and before was verified for inclusion in the guidelines. Evidence from January 2001 to January 2007 were reviewed to generate an unrefined "combined evidence" database using a search strategy focused on answering clinical questions relevant to cytomegalovirus and solid organ transplantation and employing a combination of Boolean searching on human-indexed thesaurus terms (Medical Subject Headings [MeSH] headings using an OVID Medline interface) and "natural language" searching on words in the title abstract and indexing terms. The citations were reduced by eliminating duplicates non-English articles and adult articles. The resulting abstracts were reviewed by a methodologist to eliminate low quality and irrelevant citations. During the course of the guideline development additional clinical questions were generated and subjected to the search process and some relevant review articles were identified. December 2000 was the last date for which literature was reviewed for the previous version of this guideline. The details of that review strategy are not documented. However all previous citations were reviewed for appropriateness to this revision.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Not stated

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

Review of Published Meta-Analyses
Systematic Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

The recommendations contained in this guideline were formulated by an interdisciplinary working group which performed systematic and critical literature reviews using a grading scale and examined current local clinical practices.

Recommendations have been formulated by a consensus process directed by best evidence patient and family preference and clinical expertise. During formulation of these recommendations the team members have remained cognizant of controversies and disagreements over the management of these patients. They have tried to resolve controversial issues by consensus where possible and when not possible to offer optional approaches to care in the form of information that includes best supporting evidence of efficacy for alternative choices.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

External Peer Review
Internal Peer Review

Description of Method of Guideline Validation

The guidelines have been reviewed and approved by clinical experts not involved in the development process senior management Risk Management & Corporate Compliance other appropriate hospital committees and other individuals as appropriate to their intended purposes.

Major Recommendations

Each recommendation is followed by evidence grades (A-X) identifying the type of supporting evidence. Definitions of the evidence grades are presented at the end of the "Major Recommendations" field.

Laboratory Assessment

  1. It is recommended that cytomegalovirus (CMV) status of donors and recipients be tested pre-transplant to stratify risk (Badley et al. 1997 [B]; Flechner et al. 1999 [C]; Humar et al. 1999 [C]; Blok et al. 1998 [C]; Sakamaki et al. 1997 [C]; Solans et al. 1995 [C]; Muir et al. 1998 [D]; Abecassis et al. 1996 [D]; Martin 1995 [S]; Snydman 1994 [S]).

    Note: The specific laboratory tests are described (see table 3 in the original guideline document).

Prophylactic Approach

Recommendations for CMV disease prophylaxis in solid organ transplant recipients are based on the previously defined risk levels (see table 2 in the original guideline document) and treatment effectiveness (see table 4 in the original guideline document).

Solid Organ (see algorithm 1 in the original guideline document)

Laboratory Evaluation

  1. It is recommended that patients receiving prophylaxis for CMV be assessed regularly for evidence of CMV disease by clinical examination (Local Consensus [E]).
  2. No specific recommendations regarding laboratory screening for CMV disease in patients receiving prophylaxis are made because of lack of evidence.

Prophylactic Therapy (see table 5 in the original guideline document for specific dosages and duration of therapy)

  1. It is recommended that CMV prophylaxis be initiated for all high and intermediate risk solid organ transplant recipients (Hodson et al. 2005 [M]; Lowance et al. 1999 [A]; Merigan et al. 1992 [A]; Macdonald et al. 1995 [B]; Martin et al. 1994 [B]; Nichols & Boeckh 2000 [S]; Patel et al. 1996 [S]). Such prophylaxis includes intravenous ganciclovir at induction doses for 14 days (Merigan et al. 1992 [A]; Cohen et al. 1993 [B]) followed by oral ganciclovir capsules for three months (Winston & Busuttil 2003 [B] 2004 [C]; Rubin et al. 2000 [C]; Pescovitz et al. 1997 [C]; Local Consensus [E]).

    Note 1: In adult renal and liver transplant recipients oral ganciclovir therapy has been reportedly used for the entire 3-month period (Gane et al. 1997 [A]; Flechner et al. 1998 [B]; Kletzmayr et al. 2000 [C]; Brennan et al. 1997 [C]).

    • In kidney recipients oral valganciclovir for 100 days has been shown to be as clinically effective as oral ganciclovir for CMV prevention (Paya et al. 2004 [A]). In heart recipients valganciclovir is also presumed to be effective but data are more limited (see Table 6 in the original guideline document (Paya et al. 2004 [A]).

      Note 1: Oral valganciclovir has been shown to have equivalent bioavailability to intravenous (IV) ganciclovir in adult liver transplant recipients (Pescovitz et al. 2000 [B]). Preliminary data suggest similar results in children (Bouw et al. 2006 [B]).

      Note 2: A higher incidence of neutropenia is reported in patients on valganciclovir 8.2% versus 3.2% ganciclovir (Paya et al. 2004 [A]).

      Note 3: In the liver transplant subpopulation there was a higher incidence of overall CMV disease and a significant increase in tissue-invasive CMV disease in the valganciclovir arm vs the ganciclovir arm (14% vs 3%) (Paya et al. 2004 [A]). Accordingly the U.S. Food and Drug Administration (FDA) has cautioned against the use of valganciclovir in liver recipients (see Table 6 in the original guideline document) (Roche Pharmaceuticals 2003 [E]).

  1. If a patient is unable to tolerate the above regimen due to adverse effects of the medication or inability to take capsules the following options may be considered:
    • Intravenous ganciclovir at induction doses for 14 days followed by oral ganciclovir suspension for three months (limited data in pediatric patients): (Pescovitz et al. 1997 [C]; Local Consensus [E])
    • Intravenous ganciclovir at induction doses for 14 days in combination with CMV hyperimmune globulin (Ham et al. 1995 [D]; Bonham 2000 [S]; Martin 1995 [S])
    • CMV hyperimmune globulin alone (Glowacki & Smaill 1994 [M]; Snydman et al. 1987 [A]; Saliba et al. 1989 [B]; Kathawalla et al. 1996 [D]; Basadonna et al. 1994 [D]; Arbo et al. 2000 [Q])
    • Intravenous ganciclovir daily for 30 days followed by intravenous ganciclovir Monday through Friday until day +100 (Glowacki & Smaill 1994 [M]; Winston et al. 1995 [A])

      Note: Ganciclovir requires a dosage adjustment in patients with renal dysfunction (Taketomo Hodding & Kraus 2000 [O]). (see Tables 7 through 9 in the original guideline document)

  1. In low risk solid organ transplant recipients there is insufficient evidence to make specific recommendations regarding the use of antiviral agents for CMV prophylaxis (Local Consensus [E]). Instead ongoing clinical surveillance for signs and symptoms of CMV disease appears reasonable (Local Consensus [E]).

Clinical Assessment

  1. It is recommended that patients with any of the following clinical conditions be considered at risk for primary infection or reactivation of CMV disease and be treated accordingly.
    • Fever
    • Hepatitis
    • Muscle pain
    • Gastroenteropathy
    • Leukopenia
    • Pneumonitis
    • Thrombocytopenia
    • Retinitis
  1. Quantitative Polymerase Chain Reaction (PCR)

    Note 1: Measurement of quantitative CMV viral load (PCR) may have the potential to identify patients at imminent risk of CMV disease and may be a useful monitoring tool during antiviral treatment a determinant of adequacy of treatment and a predictor of CMV relapse (Emery et al. 2000 [C]; Sia et al. 2000 [C]).

Definitions:

Evidence Based Grading Scale:

M: Meta-analysis or systematic review
A: Randomized controlled trial: large sample
B: Randomized controlled trial: small sample
C: Prospective trial or large case series
D: Retrospective analysis
O: Other evidence
S: Review article
E: Expert opinion or consensus
F: Basic laboratory research
L: Legal requirement
Q: Decision analysis
X: No evidence

Clinical Algorithm(s)

A clinical algorithm is provided in the original guideline document for "Solid Organ Transplant Prophylactic Approach."

References Supporting the Recommendations

  • Abecassis MM Koffron AJ Kaplan B Buckingham M Muldoon JP Cribbins AJ Kaufman DB Fryer JP Stuart J Stuart FP. Role of PCR in the diagnosis and management of CMV in solid organ recipients: what is the predictive value for the development of disease and should PCR be used to guide antiviral therapy. Transplant Proc 1996 Dec;28(6 Suppl 2):2-4. [18 references] PubMed


  • Arbo MD Snydman DR Wong JB Goldberg HS Schmid CH Pauker SG. Cytomegalovirus immune globulin after liver transplantation: a cost-effectiveness analysis. Clin Transplant 2000 Feb;14(1):19-27. PubMed


  • Badley AD Seaberg EC Porayko MK Wiesner RH Keating MR Wilhelm MP Walker RC Patel R Marshall WF DeBernardi M Zetterman R Steers JL Paya CV. Prophylaxis of cytomegalovirus infection in liver transplantation: a randomized trial comparing a combination of ganciclovir and acyclovir to acyclovir. NIDDK Liver Transplantation Database. Transplantation 1997 Jul 15;64(1):66-73. PubMed


  • Basadonna G Feria A Perez R Klein H Sturges M Colquhoun S. Incidence of infection and acute rejection after cytomegalovirus immune globulin prophylaxis in renal transplantation. Transplant Proc 1994 Oct;26(5 Suppl 1):52-3. PubMed


  • Blok MJ Christiaans MH Goossens VJ van Hooff JP Top B Middeldorp JM Bruggeman CA. Evaluation of a new method for early detection of active cytomegalovirus infections. A study in kidney transplant recipients. Transpl Int 1998;11 Suppl 1:S107-9. PubMed


  • Bonham CA. Prevention and treatment of cytomegalovirus infection in liver and intestinal transplantation: a conference report from 'non-surgical issues in liver transplantation'. Miami (FL): 2000.


  • Bouw RV Walker R. Gancoclovir pharmacokinetics in pediatric solid organ transplant recipients after administration of valganciclovir oral solution [abstract]. Am J Transplant 2006 Aug;6 Suppl 2:215.


  • Brennan DC Garlock KA Singer GG Schnitzler MA Lippmann BJ Buller RS Gaudreault-Keener M Lowell JA Shenoy S Howard TK Storch GA. Prophylactic oral ganciclovir compared with deferred therapy for control of cytomegalovirus in renal transplant recipients. Transplantation 1997 Dec 27;64(12):1843-6. PubMed


  • Cohen AT O'Grady JG Sutherland S Sallie R Tan KC Williams R. Controlled trial of prophylactic versus therapeutic use of ganciclovir after liver transplantation in adults. J Med Virol 1993 May;40(1):5-9. PubMed


  • Emery VC Sabin CA Cope AV Gor D Hassan-Walker AF Griffiths PD. Application of viral-load kinetics to identify patients who develop cytomegalovirus disease after transplantation. Lancet 2000 Jun 10;355(9220):2032-6. PubMed


  • Flechner SM Avery RK Fisher R Mastroianni B Papajcik D O'Malley KJ Goormastic M Goldfarb DA Modlin CS Novick AC. Monitoring of CMV infection after renal transplantation: serology culture and viral DNA detection by hybrid capture. Transplant Proc 1999 Feb-Mar;31(1-2):1255-7. PubMed


  • Flechner SM Avery RK Fisher R Mastroianni BA Papajcik DA O'Malley KJ Goormastic M Goldfarb DA Modlin CS Novick AC. A randomized prospective controlled trial of oral acyclovir versus oral ganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Transplantation 1998 Dec 27;66(12):1682-8. PubMed


  • Gane E Saliba F Valdecasas GJ O'Grady J Pescovitz MD Lyman S Robinson CA. Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver-transplant recipients. The Oral Ganciclovir International Transplantation Study Group [corrected]. Lancet 1997 Dec 13;350(9093):1729-33. PubMed


  • Glowacki LS Smaill FM. Use of immune globulin to prevent symptomatic cytomegalovirus disease in transplant recipients--a meta-analysis. Clin Transplant 1994 Feb;8(1):10-8. PubMed


  • Ham JM Shelden SL Godkin RR Posner MP Fisher RA. Cytomegalovirus prophylaxis with ganciclovir acyclovir and CMV hyperimmune globulin in liver transplant patients receiving OKT3 induction. Transplant Proc 1995 Oct;27(5 Suppl 1):31-3. PubMed


  • Hodson EM Jones CA Webster AC Strippoli GF Barclay PG Kable K Vimalachandra D Craig JC. Antiviral medications to prevent cytomegalovirus disease and early death in recipients of solid-organ transplants: a systematic review of randomised controlled trials. Lancet 2005 Jun 18-24;365(9477):2105-15. [55 references] PubMed


  • Humar A Gregson D Caliendo AM McGeer A Malkan G Krajden M Corey P Greig P Walmsley S Levy G Mazzulli T. Clinical utility of quantitative cytomegalovirus viral load determination for predicting cytomegalovirus disease in liver transplant recipients. Transplantation 1999 Nov 15;68(9):1305-11. PubMed


  • Kathawalla SA Stillwell PC Gordon S Haug M Perl M Arroliga AC Mehta AC Avery R Kirby T. Cytomegalovirus infection in seromismatched lung transplant recipients with and without prophylaxis with CMV immunoglobulin. Transplant Proc 1996;28(6 suppl 2) PubMed


  • Kletzmayr J Kreuzwieser E Watkins-Riedel T Berlakovich G Kovarik J Klauser R. Long-term oral ganciclovir prophylaxis for prevention of cytomegalovirus infection and disease in cytomegalovirus high-risk renal transplant recipients. Transplantation 2000 Oct 27;70(8):1174-80. PubMed


  • Lowance D Neumayer HH Legendre CM Squifflet JP Kovarik J Brennan PJ Norman D Mendez R Keating MR Coggon GL Crisp A Lee IC. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. International Valacyclovir Cytomegalovirus Prophylaxis Transplantation Study Group. N Engl J Med 1999 May 13;340(19):1462-70. PubMed


  • Macdonald PS Keogh AM Marshman D Richens D Harvison A Kaan AM Spratt PM. A double-blind placebo-controlled trial of low-dose ganciclovir to prevent cytomegalovirus disease after heart transplantation. J Heart Lung Transplant 1995 Jan-Feb;14(1 Pt 1):32-8. PubMed


  • Martin M Manez R Linden P Estores D Torre-Cisneros J Kusne S Ondick L Ptachcinski R Irish W Kisor D et al.. A prospective randomized trial comparing sequential ganciclovir-high dose acyclovir to high dose acyclovir for prevention of cytomegalovirus disease in adult liver transplant recipients. Transplantation 1994 Oct 15;58(7):779-85. PubMed


  • Martin M. Prophylactic cytomegalovirus management strategies. Transplant Proc 1995 Oct;27(5 Suppl 1):23-7. [30 references] PubMed


  • Merigan TC Renlund DG Keay S Bristow MR Starnes V O'Connell JB Resta S Dunn D Gamberg P Ratkovec RM et al. A controlled trial of ganciclovir to prevent cytomegalovirus disease after heart transplantation. N Engl J Med 1992 Apr 30;326(18):1182-6. PubMed


  • Muir SW Murray J Farquharson MA Wheatley DJ McPhaden AR. Detection of cytomegalovirus in upper gastrointestinal biopsies from heart transplant recipients: comparison of light microscopy immunocytochemistry in situ hybridisation and nested PCR. J Clin Pathol 1998 Nov;51(11):807-11. PubMed


  • Nichols WG Boeckh M. Recent advances in the therapy and prevention of CMV infections. J Clin Virol 2000 Feb;16(1):25-40. [60 references] PubMed


  • Patel R Snydman DR Rubin RH Ho M Pescovitz M Martin M Paya CV. Cytomegalovirus prophylaxis in solid organ transplant recipients. Transplantation 1996 May 15;61(9):1279-89. [58 references] PubMed


  • Paya C Humar A Dominguez E Washburn K Blumberg E Alexander B Freeman R Heaton N Pescovitz MD Valganciclovir Solid Organ Transplant Study Group. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2004 Apr;4(4):611-20. PubMed


  • Pescovitz MD Brook B Jindal RM Leapman SB Milgrom ML Filo RS. Oral ganciclovir in pediatric transplant recipients: a pharmacokinetic study. Clin Transplant 1997 Dec;11(6):613-7. PubMed


  • Pescovitz MD Rabkin J Merion RM Paya CV Pirsch J Freeman RB O'Grady J Robinson C To Z Wren K Banken L Buhles W Brown F. Valganciclovir results in improved oral absorption of ganciclovir in liver transplant recipients. Antimicrob Agents Chemother 2000 Oct;44(10):2811-5. PubMed


  • Roche Pharmaceuticals. Letter regarding FDA safety alert: Valcyte (valganciclovir HCI tablets). Rockville (MD): Food and Drug Administration; 2003.


  • Rubin RH Kemmerly SA Conti D Doran M Murray BM Neylan JF Pappas C Pitts D Avery R Pavlakis M Del Busto R DeNofrio D Blumberg EA Schoenfeld DA Donohue T Fisher SA Fishman JA. Prevention of primary cytomegalovirus disease in organ transplant recipients with oral ganciclovir or oral acyclovir prophylaxis. Transpl Infect Dis 2000 Sep;2(3):112-7. PubMed


  • Sakamaki H Yuasa K Goto H Tanikawa S Akiyama H Onozawa Y Okamoto R Maeda Y Sasaki T Kaku H Tsuzuki S Takamoto S Mochida Y Minematsu T Minamishima Y. Comparison of cytomegalovirus (CMV) antigenemia and CMV in bronchoalveolar lavage fluid for diagnosis of CMV pulmonary infection after bone marrow transplantation. Bone Marrow Transplant 1997 Jul;20(2):143-7. PubMed


  • Saliba F Arulnaden JL Gugenheim J Serves C Samuel D Bismuth A Mathieu D Bismuth H. CMV hyperimmune globulin prophylaxis after liver transplantation: a prospective randomized controlled study. Transplant Proc 1989 Feb;21(1 Pt 2):2260-2. PubMed


  • Sia IG Wilson JA Groettum CM Espy MJ Smith TF Paya CV. Cytomegalovirus (CMV) DNA load predicts relapsing CMV infection after solid organ transplantation. J Infect Dis 2000 Feb;181(2):717-20. PubMed


  • Snydman DR Werner BG Heinze-Lacey B Berardi VP Tilney NL Kirkman RL Milford EL Cho SI Bush HL Jr Levey AS et al. Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal-transplant recipients. N Engl J Med 1987 Oct 22;317(17):1049-54. PubMed


  • Snydman DR. Cytomegalovirus prophylaxis strategies in high-risk transplantation. Transplant Proc 1994 Oct;26(5 Suppl 1):20-2. [21 references] PubMed


  • Solans EP Garrity ER Jr McCabe M Martinez R Husain AN. Early diagnosis of cytomegalovirus pneumonitis in lung transplant patients. Arch Pathol Lab Med 1995 Jan;119(1):33-5. PubMed


  • Taketomo CK Hodding JH Kraus DM. Pediatric dosage handbook. 6th ed. Cleveland (OH): Lexi-Comp Inc.; 1999-2000.


  • Winston DJ Busuttil RW. Randomized controlled trial of oral ganciclovir versus oral acyclovir after induction with intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in cytomegalovirus-seropositive liver transplant recipients. Transplantation 2003 Jan 27;75(2):229-33. PubMed


  • Winston DJ Busuttil RW. Randomized controlled trial of sequential intravenous and oral ganciclovir versus prolonged intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in high-risk cytomegalovirus-seronegative liver transplant recipients. Transplantation 2004 Jan 27;77(2):305-8. PubMed


  • Winston DJ Wirin D Shaked A Busuttil RW. Randomised comparison of ganciclovir and high-dose acyclovir for long-term cytomegalovirus prophylaxis in liver-transplant recipients. Lancet 1995 Jul 8;346(8967):69-74. PubMed

Type of Evidence supporting the Recommendations

The type of evidence is identified and classified for each recommendation (see "Major Recommendations") using the following scheme:

Evidence Based Grading Scale:

M: Meta-analysis or systematic review
A: Randomized controlled trial: large sample
B: Randomized controlled trial: small sample
C: Prospective trial or large case series
D: Retrospective analysis
O: Other evidence
S: Review article
E: Expert opinion or consensus
F: Basic laboratory research
L: Legal requirement
Q: Decision analysis
X: No evidence

Potential Benefits

Prevent or decrease the incidence of cytomegalovirus (CMV) infection and cytomegalovirus disease and its associated significant morbidity and mortality

Potential Harms

A higher incidence of neutropenia is reported in patients on valganciclovir 8.2% versus 3.2% ganciclovir.

Contraindications

The U.S. Food and Drug Administration (FDA) has cautioned against the use of valganciclovir in liver recipients.

Qualifying Statements

These recommendations result from review of literature and practices current at the time of their formulations. This protocol does not preclude using care modalities proven efficacious in studies published subsequent to the current revision of this document. This document is not intended to impose standards of care preventing selective variances from the guidelines to meet the specific and unique requirements of individual patients. Adherence to this pathway is voluntary. The physician in light of the individual circumstances presented by the patient must make the ultimate judgment regarding the priority of any specific procedure.

Description of Implementation Strategy

Appropriate companion documents have been developed to assist in the effective dissemination and implementation of the guideline. Experience with the implementation of earlier publications of this guideline has provided learnings which have been incorporated into this revision. Incidence of cytomegalovirus (CMV) disease is an outcome measure monitored and reviewed by the transplant teams.

Implementation Tools

Clinical Algorithm
Patient Resources

For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.

IOM Care Need

Living with Illness
Staying Healthy

IOM Domain

Effectiveness
Patient-centeredness

Bibliographic Source(s)

  • Cincinnati Children's Hospital Medical Center. Evidence-based care guideline for cytomegalovirus prophylaxis following solid organ transplants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2007 Jul 6. 15 p. [68 references]

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

Cincinnati Children's Hospital Medical Center

Guideline Committee

Cardiac Clinical Pathway Team Renal & Liver Transplant Teams 2007 Revision

Composition of Group that Authored the Guideline

Cincinnati Children's Hospital Medical Center Physicians: Peter Manning MD Cardiac Surgery; Catherine Dent MD Cardiac Intensive Care/Transplant; William Border MD Cardiology; James Spaeth MD Anesthesia; Michael Alice Moga MD Cardiology/Fellow; Jeffrey Anderson MD Cardiology/Fellow; Pirooz Eghtesady MD Cardiac Surgery/Transplant; Jens Goebel MD Nephrology/Transplant; Kathleen Campbell MD Liver Transplant

Patient Services: Karen Uzark PhD CPNP Cardiology/Transplant; Joyce Slusher CPNP Cardiology/Transplant; Christa Barlow CNP Cardiac Surgery; Melissa Magness RN Cardiac ICU; Tammy Lingsch RN A6 Central; Cynthia Wedekind Pharm D Clinical Pharmacy; Jenni Raake RRT Respiratory Care; Shawna Kirkendall RN Manager A 6 Central

Clinical Effectiveness Services: Eduardo Mendez RN MPH Dir. Evidence-Based Care Facilitator; Eloise Clark MPH Guideline Program Administrator; Danette Stanko MA MPH Epidemiologist; Kate Rich Lead Decision Support Analyst; Carol Frese RN Medical Reviewer; Edward Donovan MD Medical Director Clinical Effectiveness; Carol Tierney MSN RN Education Specialist

Financial Disclosures/Conflicts of Interest

The guideline was developed without external funding.  All Team Members and Clinical Effectiveness support staff listed have declared whether they have any conflict of interest and none were identified.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children's Hospital Medical Center. Evidence based clinical practice guideline for cytomegalovirus prophylaxis following solid organ blood and marrow transplants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2001 Jun 7. 16 p. [145 references]

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Cincinnati Children's Hospital Medical Center Web site.

For information regarding the full-text guideline print copies or evidence based practice support services contact the Children's Hospital Medical Center Health Policy and Clinical Effectiveness Department at HPCEInfo@chmcc.org.

Availability of Companion Documents

None available

Patient Resources

The following Health Topics are available:

  • Cytomegalovirus (CMV). Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2006 Oct. 2 p.
  • Cytomegalovirus (CMV) in the immunocompromised patient. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2007 Jan. p. 3

Electronic copies: Available from the Cincinnati Children's Hospital Medical Center.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

This NGC summary was completed by ECRI on March 11 2004. This NGC summary was updated by ECRI Institute on February 26 2008.

COPYRIGHT STATEMENT

This NGC summary is based on the original full-text guideline which is subject to the following copyright restrictions:

Copies of Cincinnati Children's Hospital Medical Center (CCHMC) Evidence-Based Clinical Practice Guidelines (EBCG) are available online and may be distributed by any organization for the global purpose of improving child health outcomes. Examples of approved uses of CCHMC's EBCG include the following:

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Notification of CCHMC at HPCEInfo@cchmc.org for any EBCG adopted adapted implemented or hyperlinked to by a given organization and/or user is appreciated.

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