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CompletedNCT03389360Updated Mar 19, 2021

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

An observational study in Liver Transplant Infection, sponsored by National Hepatology & Tropical Medicine Research Institute. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by National Hepatology & Tropical Medicine Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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).

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.

02

Conditions studied

  • Liver Transplant Infection
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx)

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

Exclusion Criteria:

  • Patients will be excluded from the study if they are readmitted or had primary graft nonfunction.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testprocalcitonin

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

05

What researchers measure

Primary outcomes

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

    value of procalcitonin to diagnose infection in early post liver transplant period

    Time frame: average two weeks during hospital stay

06

Study locations

1 site
  • NHTMRI
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03389360
Lead sponsor
National Hepatology & Tropical Medicine Research Institute
Responsible party
ICU (Fellow of intensive care medicine, National Hepatology & Tropical Medicine Research Institute) — Principal investigator
First posted
Jan 3, 2018
Start date
Mar 15, 2018
Primary completion
Dec 20, 2018
Completion
Feb 10, 2019
Last update
Mar 19, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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