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Evaluation of Procalcitonin (PCT) as a Marker of Infection in Post-orthotopic Liver Transplant

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ClinicalTrials.gov Identifier: NCT03389360
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
, the study aimed at assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.

Condition or disease Intervention/treatment
Liver Transplant Infection Diagnostic Test: procalcitonin

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.


Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Procalcitonin (PCT) as a Marker of Infection in Post-orthotopic Liver Transplant
Actual Study Start Date : December 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
adult patients aged ≥18 years old who are recipients for living donated liver transplantation (LTx)
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Eman El-Desoki, Ph D 01227409501 eman18350@gmail.com

Locations
Egypt
NHTMRI Recruiting
Cairo, Egypt
Contact: Eman El-Desoki, Ph D    01227409501    eman18350@gmail.com   
Sponsors and Collaborators
National Hepatology & Tropical Medicine Research Institute
More Information

Responsible Party: Eman Desoki, Fellow of intensive care medicine, National Hepatology & Tropical Medicine Research Institute
ClinicalTrials.gov Identifier: NCT03389360     History of Changes
Other Study ID Numbers: NHTMRI
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs