Cerebrovascular Autoregulation During and After Liver Tra... | NCT01597102

Studies
Cerebrovascular Autoregulation During and After Liver Transplantation

NCT01597102

Sponsor

Johannes Gutenberg University Mainz

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Encephalopathy, Hepatic
Cerebrovascular Disorders
Liver Failure

Interventions

No interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2012Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Mar 31, 2021Estimated

First Submitted Date

May 7, 2012

First Submission Date that Met QC Criteria

May 9, 2012

First Posted Date

May 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schramm, Principal investigator, Johannes Gutenberg University MainzPrincipal Investigator

Lead Sponsor

Johannes Gutenberg University MainzOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver transplantation		Patients with liver failure and liver transplantation	Other: No interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No interventions	Other	No intervention is planned in this study	Liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver transplantation
age > 18 years

Exclusion Criteria:

sepsis
preexisting cerebral diseases
traumatic brain injury
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with and stage liver failure and transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Schramm, MD	Contact	00496131176755		schrammp@uni-mainz.de

Overall Officials

Name	Affiliation	Role
Patrick Schramm, MD	Johannes Gutenberg University Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center	Recruiting	Mainz		55131	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006501	Hepatic Encephalopathy
D002561	Cerebrovascular Disorders
D017093	Liver Failure

Ancestor Terms

ID	Term
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases
D001928	Brain Diseases, Metabolic

Browse Leaves

Not provided

Browse Branches

Not provided