Hypotension, Shock
Conditions
Keywords
hypotension, vasopressors, titration, tissue perfusion, organ failure
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.
Interventions
DRUGVasopressors
Sponsors
Canadian Critical Care Trials Group
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Francois Lamontagne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Liberal Approach In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.
Vasopressors | 60 |
| Restrictive Approach We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
Vasopressors | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Total | Restrictive Approach | Liberal Approach |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 13 | 66 years STANDARD_DEVIATION 13 | 63 years STANDARD_DEVIATION 13 |
| Region of Enrollment Canada | 114 participants | 57 participants | 57 participants |
| Region of Enrollment United States | 6 participants | 3 participants | 3 participants |
| Sex: Female, Male Female | 54 Participants | 29 Participants | 25 Participants |
| Sex: Female, Male Male | 66 Participants | 31 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 60 | 41 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
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).
Time frame: While on vasopressors from randomization until 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liberal Approach | MAP While on Vasopressors | 79 mmHg | Standard Deviation 5 |
| Restrictive Approach | MAP While on Vasopressors | 70 mmHg | Standard Deviation 5 |