Importance of Liver Innervation for the Osmopressor Response in Humans

Not Applicable

Completed

• Conditions: PHYSIOLOGICAL PHENOMENA
• Interventions: Dietary Supplement: 500ml water intake

• Registration Number: NCT01237431
• Lead Sponsor: Hannover Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liver transplanted patients	500ml water intake	Target group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation.
kidney transplanted patients	500ml water intake	Control group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation.

Primary Outcome Measures

Name	Time	Method
norepinephrine plasma level	30-40 minutes after water drinking

Secondary Outcome Measures

Name	Time	Method
pressure response	blood pressure 30-40 minutes after water drinking	cardiovascular changes are monitored by finapress and ICG

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, NDS, Germany