Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/10/2005
Date assigned
21/10/2005
Last edited
17/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guenter Luckner

ORCID ID

Contact details

Anichstrasse 35
Innsbruck
6020
Austria

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

http://www.i-med.ac.at

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

  1. 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.

Additional files

Editorial Notes