Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During Liver Transplantation

January 13, 2018 updated by: Heba Moharem, Alexandria University

Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During a Liver Transplantation

The present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Elmoasah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients with grade C liver cirrhosis with liver failure undergoing liver transplantation

Description

Inclusion Criteria:

• patients with liver failure undergoing liver transplantation

Exclusion Criteria:

  • Age less than 18 years;
  • Active overt infection;
  • Patients on oral or systemic anticoagulation or with known coagulopathic disorders apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital platelet disorders and congenital coagulation disorders…etc);
  • Patients undergoing re-transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DNA positive patients
patients who have bacterial DNA in their samples
Diagnostic test: PCR for bacterial translocation
samples taken from the blood and ascites of patients to search for bacterial DNA
DNA negative patients
patients who do not have bacterial DNA in their samples
Diagnostic test: PCR for bacterial translocation
samples taken from the blood and ascites of patients to search for bacterial DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in the mean arterial blood pressure
Time Frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
antifactor X activity
Time Frame: at the beginning of surgery
at the beginning of surgery
change in the heart rate
Time Frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
change in the cardiac output
Time Frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Director: ahmed mukhtar, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2017

Primary Completion (ACTUAL)

October 24, 2017

Study Completion (ACTUAL)

November 14, 2017

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 13, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 020583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Effect of Bacterial Translocation

Clinical Trials on PCR for bacterial translocation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe