Importance of Liver Innervation for the Osmopressor Response in Humans (HEP-Reflex)

February 22, 2011 updated by: Hannover Medical School

In patients with autonomic dysfunction water drinking elicits a pressor response mediated by sympathetic activation. If any, in healthy subjects there is only a slight increase in blood pressure. However, the sympathetic activation is observable by resting energy expenditure increases greater than 20%.

The investigators believe that the response to water may be mediated through sympathetic activation elicited by osmosensitve spinal afferents in the liver. Therefore, the investigators want to test water in liver transplant patients who have a denervated liver. Kidney transplant patients serve as control subjects. The investigators hypothesize that the increase in norepinephrine after water drinking is blunted in liver transplant recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NDS
      • Hannover, NDS, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3 to 24 month past liver or kidney transplantation
  • age 18 to 60
  • written informed consent
  • ability to understand the oral and written information

Exclusion Criteria:

  • pregnancy or lactation
  • transplantation of another organ
  • chronic heart or vascular disease
  • known alcohol or drug abuse
  • psychiatric diseases (e.g. chronic depression, schizophrenia, drug addiction)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: liver transplanted patients
Target group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation.
Dietary supplement: 500ml water intake
subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
Active Comparator: kidney transplanted patients
Control group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation.
Dietary supplement: 500ml water intake
subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
norepinephrine plasma level
Time Frame: 30-40 minutes after water drinking
30-40 minutes after water drinking

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pressure response
Time Frame: blood pressure 30-40 minutes after water drinking
cardiovascular changes are monitored by finapress and ICG
blood pressure 30-40 minutes after water drinking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D-MHH-Hep_Reflex-EK5413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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