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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03230214
Other study ID # 020583
Secondary ID
Status Completed
Phase N/A
First received July 20, 2017
Last updated January 13, 2018
Start date August 3, 2017
Est. completion date November 14, 2017

Study information

Verified date January 2018
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 14, 2017
Est. primary completion date October 24, 2017
Accepts healthy volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Effect of Bacterial Translocation

Intervention

Diagnostic Test:
PCR for bacterial translocation
samples taken from the blood and ascites of patients to search for bacterial DNA

Locations

Country Name City State
Egypt Elmoasah Hospital Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in the mean arterial blood pressure at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
Primary antifactor X activity at the beginning of surgery
Primary change in the heart rate at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
Primary change in the cardiac output at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase