Optimal VAsopressor titraTION Pilot Randomized Controlled Trial

Completed · Not applicable

Conditions studied: Hypotension, Shock

In brief

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 important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.

Key facts

Study ID

NCT01800877

Run by

Francois Lamontagne

People needed

120

Starts

2013-04-01

Expected to finish

2015-02-01

Last updated by the study team

2019-03-12

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mercy Hospital — St Louis, Missouri, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Queens Elizabeth II Hospital — Halifax, Nova Scotia, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Mt Sinai Hospital — Toronto, Ontario, Canada
• Sunnybrooke HSC — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Hopital L'Enfant-Jesus — Québec, Quebec, Canada
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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