Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-01 @ 1:56 AM
Study NCT ID:
NCT03389360
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2017-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant
Sponsor:
National Hepatology & Tropical Medicine Research Institute
Organization:
Study Overview
Official Title:
Evaluation of Procalcitonin (PCT) as a Marker of Infection Post Living Donated Liver Transplant
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: