Optimal VAsopressor titraTION Pilot Randomized Controlled Trial



Status:Completed
Conditions:Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:17 - Any
Updated:3/14/2019
Start Date:April 2013
End Date:February 2015

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Optimal Vasopressor Titration Pilot Randomized Controlled Trial

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.

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.

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.
We found this trial at
2
sites
Saint Louis, Missouri 63141
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Saint Louis, MO
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Edmonton, Alberta
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Edmonton,
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