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 |
| Protocol serial number | N/A |
| Sponsor | Innsbruck Medical University (Austria) |
| Funder | Innsbruck Medical University (Austria) |
- 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
Scientific
Anichstrasse 35
Innsbruck
6020
Austria
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Arginine-Vasopressin (AVP) |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Differences in the oscillation frequency of the Doppler signal between groups. |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Austria
Study participating centre
Anichstrasse 35
Innsbruck
6020
Austria
6020
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
