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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01237431
Other study ID # D-MHH-Hep_Reflex-EK5413
Secondary ID
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


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
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