- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01237431
Importance of Liver Innervation for the Osmopressor Response in Humans (HEP-Reflex)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
NDS
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Hannover, NDS, Tyskland, 30625
- Hannover Medical School
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: liver transplanted patients
Target group to confirm the hypothesis.
Transplantation has to be between 6 an 24 Month before participation.
|
subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
|
Aktiv komparator: kidney transplanted patients
Control group, age, gender and medication matched.
Transplantation has to be between 6 an 24 Month before participation.
|
subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
norepinephrine plasma level
Tidsramme: 30-40 minutes after water drinking
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30-40 minutes after water drinking
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
pressure response
Tidsramme: blood pressure 30-40 minutes after water drinking
|
cardiovascular changes are monitored by finapress and ICG
|
blood pressure 30-40 minutes after water drinking
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- D-MHH-Hep_Reflex-EK5413
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Kliniske forsøg med 500ml water intake
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