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ISRCTN
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ISRCTN52577337
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ClinicalTrials.gov identifier
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Public title
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Cutaneous vascular reactivity and flow motion response to vasopressin in advanced vasodilatory shock and severe postoperative multiple organ dysfunction syndrome
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The effects of a supplementary Arginine-Vasopressin (AVP) infusion on microcirculation in advanced vasodilatory shock and postoperative multiple organ dysfunction syndrome are unknown.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Austria
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Disease/condition/study domain
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Severe multiple organ dysfunction syndrome
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Participants - inclusion criteria
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Critically ill patients suffering of severe multiple organ dysfunction syndrome after cardiac or major surgery with a mean arterial blood pressure less than 65 mmHg despite adequate volume resuscitation, and Norepinephrine (NE) requirements greater than 0.5 µg/kg/min.
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Participants - exclusion criteria
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Patients with arterial vascular occlusive disease or insulin-dependent diabetes mellitus.
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Anticipated start date
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01/01/2004
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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18
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Interventions
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NE plus supplementary AVP (Pitressin®; Pfizer, Karlsruhe, Germany) infused at a continuous rate of 4 IU/hour versus NE alone.
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Primary outcome measure(s)
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Differences in the area under the concentration-time Area Under Curve (AUC) of the Doppler signal and the reactive hyperemic response to forearm ischaemia between AVP/NE and NE patients.
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Secondary outcome measure(s)
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Differences in the oscillation frequency of the Doppler signal between groups.
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Sources of funding
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Innsbruck Medical University (Austria)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=16542484
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Contact name
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Dr
Guenter
Luckner
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Address
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Anichstrasse 35
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City/town
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Innsbruck
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Zip/Postcode
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6020
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Country
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Austria
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Sponsor
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Innsbruck Medical University (Austria)
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Address
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Christoph-Probst-Platz
Innrain 52
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City/town
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Innsbruck
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Zip/Postcode
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6020
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Country
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Austria
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Sponsor website:
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http://www.i-med.ac.at
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Date applied
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14/10/2005
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Last edited
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17/09/2007
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Date ISRCTN assigned
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21/10/2005
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