NCT03389360

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2019

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

December 25, 2017

Last Update Submit

March 18, 2021

Conditions

Liver Transplant Infection

Outcome Measures

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

    average two weeks during hospital stay

Interventions

procalcitoninDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHTMRI

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of intensive care medicine

Study Record Dates

First Submitted

December 25, 2017

First Posted

January 3, 2018

Study Start

March 15, 2018

Primary Completion

December 20, 2018

Study Completion

February 10, 2019

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

EG(1)