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Completed

NCT Number: NCT03389360

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHTMRI

Cairo, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

procalcitonin

Diagnostic Test

assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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