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

Liver Transplant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389360
• Other study ID #: NHTMRI
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: February 10, 2019

Study information

• Verified date: March 2021
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 10, 2019
• Est. primary completion date: December 20, 2018
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Liver Transplant Infection

Intervention

Diagnostic Test:
• procalcitonin
assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.

Locations

Country	Name	City	State
Egypt	NHTMRI	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.	value of procalcitonin to diagnose infection in early post liver transplant period	average two weeks during hospital stay