Importance of Liver Innervation for the Osmopressor Response in Humans

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.

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Key information

Conditions

PHYSIOLOGICAL PHENOMENA Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Dysautonomias Pure Autonomic Failure Signs and Symptoms Syncope Unconsciousness

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, NDS, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

500ml water intake

Dietary Supplement

subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position

Primary outcomes

norepinephrine plasma level

Time frame: 30-40 minutes after water drinking

Secondary outcomes

pressure response

Time frame: blood pressure 30-40 minutes after water drinking

cardiovascular changes are monitored by finapress and ICG

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Acronym: HEP-Reflex

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Nov 9, 2010
Registry last updated: Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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