Status:
COMPLETED
Optimal VAsopressor titraTION Pilot Randomized Controlled Trial
Lead Sponsor:
Francois Lamontagne
Collaborating Sponsors:
Canadian Critical Care Trials Group
Canadian Institutes of Health Research (CIHR)
Conditions:
Hypotension
Shock
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is impor...
Detailed Description
Patients who are admitted to the intensive care unit (ICU) commonly suffer from shock, a condition that causes life-threatening low blood pressure. Low blood pressure makes it difficult for the body t...
Eligibility Criteria
Inclusion
- Who are receiving vasopressors for distributive shock
- Who are older than 16 years of age at the time of eligibility.
- Who are under the direct care of the ICU team regardless of location.
- Who have received a minimum of 30 mL/kg of intravenous fluids (2100 mL for a 70 kg patient) before enrolment OR the most responsible physician has good reasons to believe that more fluid resuscitation is no longer required and could be harmful.
- Who the treating physician believes will need vasopressors for at least 6 hours once enrolled.
Exclusion
- Have received vasopressors for more than 24 consecutive hours; if vasopressors are discontinued for \>= 2 hours then restarting vasopressors will constitute a distinct vasopressor episode and the clock will be reset.
- Are judged by the treating physician to be in obvious cardiogenic shock after an acute myocardial infarction (based on new ST segment elevations on ECG or obvious echocardiographic findings).
- Have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss.
- Require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension.
- Who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension).
- If the attending team has agreed to withhold or withdraw life sustaining care.
- Concurrent enrollment in interventional trials that do not meet guidelines (see ccctg.ca) for co-enrollment (co-enrollment is permissible if there is no potential interaction between the protocols; this will be addressed case by case).
- Prior randomization in this study.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01800877
Start Date
April 1 2013
End Date
February 1 2015
Last Update
March 12 2019
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Mercy Hospital
St Louis, Missouri, United States, 63141
2
University of Alberta Hospital
Edmonton, Alberta, Canada
3
Queens Elizabeth II Hospital
Halifax, Nova Scotia, Canada
4
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7