We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebrovascular Autoregulation During and After Liver Transplantation (dARICULtx)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597102
First Posted: May 11, 2012
Last Update Posted: January 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz
  Purpose
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.

Condition Intervention
Encephalopathy, Hepatic Cerebrovascular Disorders Liver Failure Other: No interventions

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cerebrovascular Autoregulation During and After Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Patrick Schramm, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Changes of cerebrovascular autoregulation during liver transplantation [ Time Frame: 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:
  • Time course of cerebrovascular autoregulation after liver transplantation [ Time Frame: First 4 days after transplantation ]
    Meaurement of cerebrovascular autoregulation daily for the first 4 days and calculating a time course


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver transplantation
Patients with liver failure and liver transplantation
Other: No interventions
No intervention is planned in this study
Other Name: No intervention is planned in this study

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with and stage liver failure and transplantation
Criteria

Inclusion Criteria:

  • liver transplantation
  • age > 18 years

Exclusion Criteria:

  • sepsis
  • preexisting cerebral diseases
  • traumatic brain injury
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597102


Locations
Germany
University Medical Center
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Patrick Schramm, MD Johannes Gutenberg University Mainz
  More Information

Responsible Party: Patrick Schramm, Principal investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01597102     History of Changes
Other Study ID Numbers: 837.041.10 III
First Submitted: May 7, 2012
First Posted: May 11, 2012
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Patrick Schramm, Johannes Gutenberg University Mainz:
encephalopathy, hepatic
autoregulation, cerebrovascular
liver failure
liver transplantation

Additional relevant MeSH terms:
Brain Diseases
Liver Failure
Cerebrovascular Disorders
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Liver Extracts
Hematinics