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

This study has been completed.

Sponsor:

Information provided by:

Hannover Medical School

ClinicalTrials.gov Identifier:

NCT01237431

First received: November 8, 2010

Last updated: February 22, 2011

Last verified: August 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	November 8, 2010
Last Updated Date	February 22, 2011
Start Date ^ICMJE	November 2009
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 8, 2010)	norepinephrine plasma level [ Time Frame: 30-40 minutes after water drinking ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01237431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 8, 2010)	pressure response [ Time Frame: blood pressure 30-40 minutes after water drinking ] [ Designated as safety issue: No ] cardiovascular changes are monitored by finapress and ICG
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Importance of Liver Innervation for the Osmopressor Response in Humans
Official Title ^ICMJE	Importance of Liver Innervation for the Osmopressor Response in Humans
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
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	PHYSIOLOGICAL PHENOMENA
Intervention ^ICMJE	Dietary Supplement: 500ml water intake subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
Study Arm (s)	Experimental: liver transplanted patients Target group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation. Intervention: Dietary Supplement: 500ml water intake Active Comparator: kidney transplanted patients Control group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation. Intervention: Dietary Supplement: 500ml water intake
Publications *	May M, Gueler F, Barg-Hock H, Heiringhoff KH, Engeli S, Heusser K, Diedrich A, Brandt A, Strassburg CP, Tank J, Sweep FC, Jordan J. Liver afferents contribute to water drinking-induced sympathetic activation in human subjects: a clinical trial. PLoS One. 2011;6(10):e25898. Epub 2011 Oct 7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01237431
Other Study ID Numbers ^ICMJE	D-MHH-Hep_Reflex-EK5413
Has Data Monitoring Committee	No
Responsible Party	Jens Jordan, Medical School Hannover
Study Sponsor ^ICMJE	Hannover Medical School
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hannover Medical School
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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