Cerebrovascular Autoregulation During and After Liver Transplantation

• Conditions: Encephalopathy, Hepatic; Cerebrovascular Disorders; Liver Failure
• Interventions: Other: No interventions

• Registration Number: NCT01597102
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to investigate the AR during liver transplantation, with the questions if the AR is impaired at the beginning of surgery and if there are changes in AR. For follow up the AR will be measured at the first days after transplantation at the ICU.

Detailed Description

The cerebrovascular autoregulation (AR) will be measured using transcranial doppler and calculating the index of autoregulation Mx. This measurement is continuous with online calculation. So, the possible changes over the whole time of surgery can be detected. Furthermore, the measurement of AR at the ICU will be performed daily at the same time over a measurement period of 60 Minutes and the time course of AR after liver transplantation will be described.

Study Timeline

• Study Start: 2012-01-08
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• liver transplantation
• age > 18 years

Exclusion Criteria

• sepsis
• preexisting cerebral diseases
• traumatic brain injury
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver transplantation	No interventions	Patients with liver failure and liver transplantation

Primary Outcome Measures

Name	Time	Method
Changes of cerebrovascular autoregulation during liver transplantation	During the surgery	Measuring cerebrovascular autoregulation during the whole liver transplantation and compare the index of AR at the beginning with index of AR Mx after reperfusion of the transplantated liver

Secondary Outcome Measures

Name	Time	Method
Time course of cerebrovascular autoregulation after liver transplantation	First 4 days after transplantation	Meaurement of cerebrovascular autoregulation daily for the first 4 days and calculating a time course

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Mainz, Germany