PHYSIOLOGICAL PHENOMENAHEP-ReflexNCT01237431
Importance of Liver Innervation for the Osmopressor Response in Humans
A study testing 500ml water intake in people with PHYSIOLOGICAL PHENOMENA, run by Hannover Medical School at 1 site in Germany.
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%. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- PHYSIOLOGICAL PHENOMENA
- What is being tested?
- 500ml water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 3 to 24 month past liver or kidney transplantation
- age 18 to 60
- written informed consent
- ability to understand the oral and written information
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- PHYSIOLOGICAL PHENOMENA
- Being tested
- 500ml water intake
- Keywords
- Water drinking, osmoreceptors, autonomic failure, syncope, blood pressure, liver transplant
- Medical subject headings
- Pure Autonomic Failure, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500ml water intakeDietary supplement
subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
| Study group | Role | What they receive |
|---|---|---|
| liver transplanted patients | Experimental | Target group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation. Receives: Dietary Supplement: 500ml water intake |
| kidney transplanted patients | Active comparator | Control group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation. Receives: Dietary Supplement: 500ml water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
norepinephrine plasma level
Measured: 30-40 minutes after water drinking
Secondary outcomes (1)
pressure response
cardiovascular changes are monitored by finapress and ICG
Measured: blood pressure 30-40 minutes after water drinking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PHYSIOLOGICAL PHENOMENAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237431
- Sponsor's protocol ID
- D-MHH-Hep_Reflex-EK5413
- Acronym
- HEP-Reflex
- Status last verified
- Aug 2009
- First submitted
- 8 Nov 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1371/journal.pone.0025898. Epub 2011 Oct 7.
PubMed 22016786
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Liver Innervation for the Osmopressor Response in Humans
- ClinicalTrials.gov ID
- NCT01237431
- Acronym / sponsor ID
- HEP-Reflex / D-MHH-Hep_Reflex-EK5413
- Conditions
- PHYSIOLOGICAL PHENOMENA
- Keywords
- Water drinking, osmoreceptors, autonomic failure, syncope, blood pressure, liver transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver transplanted patients | Experimental | Dietary Supplement: 500ml water intakeTarget group to confirm the hypothesis. Transplantation has to be between 6 an 24 Month before participation. |
| kidney transplanted patients | Active comparator | Dietary Supplement: 500ml water intakeControl group, age, gender and medication matched. Transplantation has to be between 6 an 24 Month before participation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 3 to 24 month past liver or kidney transplantation
- age 18 to 60
- written informed consent
- ability to understand the oral and written information
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500ml water intakesubjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position | Dietary supplement | kidney transplanted patients, liver transplanted patients |
Primary outcome
norepinephrine plasma level
Time frame: 30-40 minutes after water drinking
1 secondary outcome
pressure response
Time frame: blood pressure 30-40 minutes after water drinking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
- Derived from this study: PubMed 22016786May 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. doi: 10.1371/journal.pone.0025898. Epub 2011 Oct 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500ml water intake in people with PHYSIOLOGICAL PHENOMENA, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
norepinephrine plasma level (time frame: 30-40 minutes after water drinking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.