Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant
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|ClinicalTrials.gov Identifier: NCT03389360|
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : February 9, 2018
|Condition or disease||Intervention/treatment|
|Liver Transplant Infection||Diagnostic Test: procalcitonin|
All patients transferred from operative theatre to ICU will be sedated, intubated & ventilated. They will receive empiric antimicrobial prophylaxis upon admission & early immunosuppression according to the clinical practice guidelines in our center, (Appendix 1).
Preoperative patients' demographic data will be obtained. Model for end-stage liver disease (MELD) prior transplant, the primary cause of liver transplant.
Operative & anesthetic details; operation time, units of blood, blood products transfusion, ischemic time, type of preservatives used, back table procedures, extra-hepatic procedure & graft to recipient weight ratio will be recorded.
Postoperative patient evaluation will include; Sequential Organ Failure Assessment (SOFA) on admission & /48h. Hemodynamic monitoring will include hourly measurement of heart rate, mean arterial pressure (MAP), temperature, central venous pressure (CVP), arterial oxygen saturation (SaO2), daily total volume of fluid infused, urine output, fluid balance daily, blood gases / 6h & daily mean values will be recorded till hospital discharge.
Routine laboratory workup includes biochemical markers of liver, kidney function and hematological parameters (complete blood count & coagulation profile).
Patient evaluation for infection will be done through scheduled measurements of PCT every other day during ICU stay & upon needed during the hospital stay. Other markers of infections will be measured till hospital discharge as C-reactive protein (CRP) every other day, daily total leukocyte count (TLC) & band cells %.
Microbiological evidence of infection will be confirmed by cultures that will be regularly sampled every other day during ICU stay & upon any clinical or laboratory biomarker suggestive of infection.
Management of suspected infection; when PCT value rising with clinical, radiological &/or laboratory evidence of infection (TLC, CRP, band%), culture from suspected site of infection will be withdrawn. If the source of infection is not evident, cultures from; blood, urine, sputum, surgical wound, drain & nasal swab will be withdrawn & empiric antimicrobial against gram +ve bacteria will be initiated. While the management of proven infection will be culture based antimicrobial initiation.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
- Diagnostic Test: procalcitonin
assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
- frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx. [ Time Frame: average two weeks during hospital stay ]value of procalcitonin to diagnose infection in early post liver transplant period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389360