Cerebrovascular Autoregulation During and After Liver Transplantation

NCT01597102 | Unknown

• 1 other identifier: 837.041.10 III
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Encephalopathy, Hepatic; Cerebrovascular Disorders; Liver Failure

Keywords

encephalopathy, hepatic; autoregulation, cerebrovascular; liver failure; liver transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time course of cerebrovascular autoregulation after liver transplantation

  First 4 days after transplantation

Study Arms (1)

Liver transplantation

Patients with liver failure and liver transplantation

Other: No interventions

Interventions

No interventions OTHER

No intervention is planned in this study

Also known as: No intervention is planned in this study

Liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with and stage liver failure and transplantation

You may qualify if:

• liver transplantation
• age \> 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Medical Center

Mainz, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy; Cerebrovascular Disorders; Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrick Schramm, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Schramm, MD

CONTACT

00496131176755; schrammp@uni-mainz.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 11, 2012
• Study Start: January 8, 2012
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

DE (1)