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Cerebrovascular Autoregulation During and After Liver Transplantation (dARICULtx)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01597102
First received: May 7, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Changes of cerebrovascular autoregulation during liver transplantation [ Time Frame: During the surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597102

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

No publications provided

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
Study First Received: May 7, 2012
Last Updated: January 9, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Cerebrovascular Disorders
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hepatic Insufficiency
Liver Diseases
 Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013