Optimal VAsopressor titraTION Pilot Randomized Controlled Trial

Hypotension Clinical Trial

— OVATION  

Official title:

Optimal Vasopressor Titration Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800877
• Other study ID #: OVATION
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2019
• Source: Clinical Evaluation Research Unit at Kingston General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Shock

Intervention

Drug:
• Vasopressors

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queens Elizabeth II Hospital	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Hopital L'Enfant-Jesus	Quebec City	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Mt Sinai Hospital	Toronto	Ontario
Canada	Sunnybrooke HSC	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Mercy Hospital	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Francois Lamontagne	Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	While on vasopressors from randomization until 28 days