Importance of Liver Innervation for the Osmopressor Response in Humans

PHYSIOLOGICAL PHENOMENA Clinical Trial

— HEP-Reflex  

Official title:

Importance of Liver Innervation for the Osmopressor Response in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237431
• Other study ID #: D-MHH-Hep_Reflex-EK5413
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: February 22, 2011
• Start date: November 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• PHYSIOLOGICAL PHENOMENA

Intervention

Dietary Supplement:
• 500ml water intake
subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	NDS

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	norepinephrine plasma level		30-40 minutes after water drinking	No
Secondary	pressure response	cardiovascular changes are monitored by finapress and ICG	blood pressure 30-40 minutes after water drinking	No