Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The effects of a supplementary Arginine-Vasopressin (AVP) infusion on microcirculation in advanced vasodilatory shock and postoperative multiple organ dysfunction syndrome are unknown.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Severe multiple organ dysfunction syndrome
Intervention
NE plus supplementary AVP (Pitressin®; Pfizer, Karlsruhe, Germany) infused at a continuous rate of 4 IU/hour versus NE alone.
Intervention type
Drug
Phase
Not Specified
Drug names
Arginine-Vasopressin (AVP)
Primary outcome measures
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.
Secondary outcome measures
Differences in the oscillation frequency of the Doppler signal between groups.
Overall trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
Patients with arterial vascular occlusive disease or insulin-dependent diabetes mellitus.
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Austria
Trial participating centre
Anichstrasse 35
Innsbruck
6020
Austria
Sponsor information
Organisation
Innsbruck Medical University (Austria)
Sponsor details
Christoph-Probst-Platz
Innrain 52
Innsbruck
6020
Austria
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Innsbruck Medical University (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=16542484
Publication citations
-
Results
Luckner G, Dünser MW, Stadlbauer KH, Mayr VD, Jochberger S, Wenzel V, Ulmer H, Pajk W, Hasibeder WR, Friesenecker B, Knotzer H, Cutaneous vascular reactivity and flow motion response to vasopressin in advanced vasodilatory shock and severe postoperative multiple organ dysfunction syndrome., Crit Care, 2006, 10, 2, R40, doi: 10.1186/cc4845.