Cutaneous vascular reactivity and flow motion response to vasopressin in advanced vasodilatory shock and severe postoperative multiple organ dysfunction syndrome

ISRCTN ISRCTN52577337
DOI https://doi.org/10.1186/ISRCTN52577337
Secondary identifying numbers N/A
Submission date
14/10/2005
Registration date
21/10/2005
Last edited
17/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Guenter Luckner
Scientific

Anichstrasse 35
Innsbruck
6020
Austria

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe effects of a supplementary Arginine-Vasopressin (AVP) infusion on microcirculation in advanced vasodilatory shock and postoperative multiple organ dysfunction syndrome are unknown.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSevere multiple organ dysfunction syndrome
InterventionNE plus supplementary AVP (Pitressin®; Pfizer, Karlsruhe, Germany) infused at a continuous rate of 4 IU/hour versus NE alone.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Arginine-Vasopressin (AVP)
Primary outcome measureDifferences 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 measuresDifferences in the oscillation frequency of the Doppler signal between groups.
Overall study start date01/01/2004
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants18
Key inclusion criteriaCritically 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.
Key exclusion criteriaPatients with arterial vascular occlusive disease or insulin-dependent diabetes mellitus.
Date of first enrolment01/01/2004
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Austria

Study participating centre

Anichstrasse 35
Innsbruck
6020
Austria

Sponsor information

Innsbruck Medical University (Austria)
University/education

Christoph-Probst-Platz
Innrain 52
Innsbruck
6020
Austria

Website http://www.i-med.ac.at
ROR logo "ROR" https://ror.org/03pt86f80

Funders

Funder type

University/education

Innsbruck Medical University (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/01/2006 Yes No