Optimal Vasopressor Titration (OVATION)
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|ClinicalTrials.gov Identifier: NCT01800877|
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : April 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypotension Shock||Drug: Vasopressors||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Vasopressor Titration Pilot Randomized Controlled Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||February 2015|
In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.
We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
- Difference in the means of MAP while on vasopressors [ Time Frame: 2 years ]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).
- Number of Protocol Violations [ Time Frame: 2 years ]We will capture the number of protocol violations, defined as a mean arterial pressure (MAP) consistently outside the permitted range for 4 consecutive hours or more while on vasopressors with no attempt to implement corrective measures.
- Number of Cross-overs [ Time Frame: 2 years ]We will quantify the number of cross-overs (patients whose mean arterial pressure corresponds to the target of the other arm for 8 consecutive hours while on vasopressors).
- Eligible patients not enrolled [ Time Frame: 2 years ]Number of eligible patients not enrolled.
- Time allowed in BP range while on vasopressors [ Time Frame: 2 years ]Time in allowed blood pressure range while on a continuous vasopressor infusion.
- Time with BP above/below allowed range [ Time Frame: 2 years ]Time with blood pressure above and below allowed range.
- Tissue Perfusion [ Time Frame: 2 years ]Clinical endpoint - time to resolution of lactic acidosis within 28 days, censored for death as an early measure of treatment success
- Organ Function [ Time Frame: 2 years ]Clinical endopoint - time to resolution of every organ failure
- Complications of vasopressor use [ Time Frame: 2 years ]clinical endpoint - We plan to monitor complications of vasopressor use including the number of patients with cardiac arrhythmias, myocardial injury as detected by daily troponin levels, bowel ischemia requiring surgery, and digit necrosis.
- Important Interventions [ Time Frame: 2 years ]Duration and total amount of important interventions such as vasopressors, central venous catheters, arterial lines, intravenous fluid volumes, inotropes, corticosteroids, days in ICU will be recorded to describe overall resource use in each arm.
- Mortality [ Time Frame: 2 years ]Clinical endpoint - we will record ICU, Hospital and 6-month mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800877
|United States, Missouri|
|St. Louis, Missouri, United States|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada|
|Canada, Nova Scotia|
|Queens Elizabeth II Hospital|
|Halifax, Nova Scotia, Canada|
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada|
|Mt Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Toronto, Ontario, Canada|
|Toronto General Hospital|
|Toronto, Ontario, Canada|
|Quebec City, Quebec, Canada|
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Francois Lamontagne, MD||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|