Cerebrovascular Autoregulation During and After Liver Transplantation

Cerebrovascular Disorders Clinical Trial

— dARICULtx  

Official title:

Cerebrovascular Autoregulation During and After Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01597102
• Other study ID #: 837.041.10 III
• Status: Recruiting
• Start date: January 8, 2012
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2020
• Source: Johannes Gutenberg University Mainz
• Contact: Patrick Schramm, MD
• Phone: 00496131176755
• Email: schrammp[@]uni-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• liver transplantation

• age > 18 years

Exclusion Criteria:

• sepsis

• preexisting cerebral diseases

• traumatic brain injury

• pregnancy

Related Conditions & MeSH terms

• Brain Diseases
• Cerebrovascular Disorders
• Encephalopathy, Hepatic
• Hepatic Encephalopathy
• Hepatic Insufficiency
• Liver Failure

Intervention

Other:
• No interventions
No intervention is planned in this study

Locations

Country	Name	City	State
Germany	University Medical Center	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of cerebrovascular autoregulation during liver transplantation	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	During the surgery
Secondary	Time course of cerebrovascular autoregulation after liver transplantation	Meaurement of cerebrovascular autoregulation daily for the first 4 days and calculating a time course	First 4 days after transplantation