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Clinical Trials/NCT03389360
NCT03389360CompletedNot Applicable

Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant

National Hepatology & Tropical Medicine Research Institute1 site in 1 country60 target enrollmentStarted: March 15, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.

Study Overview

Brief Summary

, the study aimed at assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.

Detailed Description

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • including adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx) at the Department of Liver Transplant of National Hepatology & Tropical Medicine Research Institute (NHTMRI), between January 2014 and January 2018 & with no contraindications for early immunosuppression.

Exclusion Criteria

  • Patients will be excluded from the study if they are readmitted or had primary graft nonfunction.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

ICU

Fellow of intensive care medicine

National Hepatology & Tropical Medicine Research Institute

Study Sites (1)

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