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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Guenter Luckner
Scientific

Anichstrasse 35
Innsbruck
6020
Austria

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Arginine-Vasopressin (AVP)
Primary outcome measure	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 study start date	01/01/2004
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	18
Key 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.
Key exclusion criteria	Patients with arterial vascular occlusive disease or insulin-dependent diabetes mellitus.
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2004

Anichstrasse 35

Innsbruck
6020
Austria

Innsbruck Medical University (Austria)
University/education

Christoph-Probst-Platz
Innrain 52
Innsbruck
6020
Austria

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

University/education

Innsbruck Medical University (Austria)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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