Optimal VAsopressor titraTION Pilot Randomized Controlled Trial
OVATION
Optimal Vasopressor Titration Pilot Randomized Controlled Trial
1 other identifier
interventional
120
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2013
CompletedFirst Posted
Study publicly available on registry
February 28, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 12, 2019
CompletedMarch 12, 2019
February 1, 2019
1.7 years
February 26, 2013
January 31, 2019
February 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MAP While on Vasopressors
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).
While on vasopressors from randomization until 28 days
Study Arms (2)
Liberal Approach
OTHERIn the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.
Restrictive Approach
OTHERWe will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Francois Lamontagnelead
- Canadian Critical Care Trials Groupcollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
- Fonds de la Recherche en Santé du Québeccollaborator
Study Sites (10)
Mercy Hospital
St Louis, Missouri, 63141, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
Queens Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Mt Sinai Hospital
Toronto, Ontario, M5G 1X5, 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, J1H 5N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marie-Hélène Masse
- Organization
- Centre de Recherche du CHUS
Study Officials
- PRINCIPAL INVESTIGATOR
Francois Lamontagne, MD
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Universite de Sherbrooke
Study Record Dates
First Submitted
February 26, 2013
First Posted
February 28, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
March 12, 2019
Results First Posted
March 12, 2019
Record last verified: 2019-02