Optimal VAsopressor titraTION Pilot Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Shock; Hypotension
• Interventions: Drug: Vasopressors

• Registration Number: NCT01800877
• Lead Sponsor: Francois Lamontagne

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

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 to deliver blood to all of its organs. The standard treatment doctors in the ICU use for their patients is to give medications that help increase blood pressure. These medications are called vasopressors. There can be side effects related to using vasopressors. 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.

Study Timeline

• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-02-28
• Study Start: 2013-04
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Results First Submitted: 2019-01-31
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-19
• Last Update Submitted: 2019-02-19
• Results First Posted: 2019-03-12
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Who are receiving vasopressors for distributive shock
2. Who are older than 16 years of age at the time of eligibility.
3. Who are under the direct care of the ICU team regardless of location.
4. 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.
5. Who the treating physician believes will need vasopressors for at least 6 hours once enrolled.

Exclusion Criteria

1. 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.
2. 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).
3. Have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss.
4. Require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension.
5. Who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension).
6. If the attending team has agreed to withhold or withdraw life sustaining care.
7. 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).
8. Prior randomization in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Approach	Vasopressors	In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.
Restrictive Approach	Vasopressors	We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.

Primary Outcome Measures

Name	Time	Method
MAP While on Vasopressors	While on vasopressors from randomization until 28 days	The primary feasibility outcome will be the difference in the means of mean arterial pressures (MAP) while on vasopressors and we define acceptable adherence (the threshold for feasibility) by a difference of at least 5 mmHg while on vasopressors (rejecting the null hypothesis of a difference of less than 5 mmHg - see proposed sample size).

Trial Locations

Locations (10)

Hopital L'Enfant-Jesus; 🇨🇦 Quebec City, Quebec, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Queens Elizabeth II Hospital; 🇨🇦 Halifax, Nova Scotia, Canada

Mercy Hospital; 🇺🇸 Saint Louis, Missouri, United States

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