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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01597102
Other study ID # 837.041.10 III
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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