Clinical trial NCT01800877: Optimal VAsopressor titraTION Pilot Randomized Controlled Trial
Official title: Optimal Vasopressor Titration Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Shock
Keywords: hypotension
vasopressors
titration
tissue perfusion
organ failure
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Critical Care Trials Group
name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
First posted: 2013-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MAP While on Vasopressors
timeFrame: While on vasopressors from randomization until 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queens Elizabeth II Hospital
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mt Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrooke HSC
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Quebec City
country: Canada
facility: Hopital L'Enfant-Jesus
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Francois Lamontagne, MD
role: PRINCIPAL_INVESTIGATOR
References: