Trial Outcomes & Findings for Optimal VAsopressor titraTION Pilot Randomized Controlled Trial (NCT NCT01800877)

Last Updated: 2019-03-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

While on vasopressors from randomization until 28 days

Results posted on

2019-03-12

Participant Flow

From April 2013 to August 2014, intensive care units (ICUs) at 11 academic hospitals in Canada and the USA participated in this open-label randomized controlled trial with approval from their local research ethics boards.

Participant milestones

Participant milestones
Measure	Liberal Approach In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors	Restrictive Approach We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Vasopressors
Overall Study STARTED	60	60
Overall Study COMPLETED	58	60
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimal VAsopressor titraTION Pilot Randomized Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liberal Approach n=60 Participants In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors	Restrictive Approach n=60 Participants We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Vasopressors	Total n=120 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 13 • n=5 Participants	66 years STANDARD_DEVIATION 13 • n=7 Participants	65 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment Canada	57 participants n=5 Participants	57 participants n=7 Participants	114 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: While on vasopressors from randomization until 28 days

Outcome measures

Outcome measures
Measure	Liberal Approach n=58 Participants In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors	Restrictive Approach n=60 Participants We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Vasopressors
MAP While on Vasopressors	79 mmHg Standard Deviation 5	70 mmHg Standard Deviation 5

Adverse Events

Liberal Approach

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Restrictive Approach

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Liberal Approach n=60 participants at risk In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors	Restrictive Approach n=60 participants at risk We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Vasopressors
Cardiac disorders Cardiac arrythmia	35.0% 21/60 • Number of events 22	20.0% 12/60 • Number of events 13
Cardiac disorders Myocardial injury	15.0% 9/60 • Number of events 9	18.3% 11/60 • Number of events 11
Gastrointestinal disorders Bowel ischemia	3.3% 2/60 • Number of events 2	6.7% 4/60 • Number of events 4
Vascular disorders Digit or limb necrosis	1.7% 1/60 • Number of events 1	5.0% 3/60 • Number of events 3
Gastrointestinal disorders Gastric feeding intolerance	11.7% 7/60 • Number of events 7	10.0% 6/60 • Number of events 6
Vascular disorders Venous thromboembolic event	3.3% 2/60 • Number of events 2	1.7% 1/60 • Number of events 1
Blood and lymphatic system disorders Major bleeding	5.0% 3/60 • Number of events 3	6.7% 4/60 • Number of events 4

Additional Information

Marie-Hélène Masse

Centre de Recherche du CHUS

Phone: 819-346-1110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place