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Optimal VAsopressor titraTION Pilot Randomized Controlled Trial (OVATION)

Primary Purpose

Hypotension, Shock

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vasopressors
Sponsored by
Francois Lamontagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring hypotension, vasopressors, titration, tissue perfusion, organ failure

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mercy Hospital
  • University of Alberta Hospital
  • Queens Elizabeth II Hospital
  • Kingston General Hospital
  • The Ottawa Hospital
  • Mt Sinai Hospital
  • Sunnybrooke HSC
  • Toronto General Hospital
  • Hopital L'Enfant-Jesus
  • Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Liberal Approach

Restrictive Approach

Arm Description

In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.

We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 26, 2013
Last Updated
February 19, 2019
Sponsor
Francois Lamontagne
Collaborators
Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT01800877
Brief Title
Optimal VAsopressor titraTION Pilot Randomized Controlled Trial
Acronym
OVATION
Official Title
Optimal Vasopressor Titration Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francois Lamontagne
Collaborators
Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Shock
Keywords
hypotension, vasopressors, titration, tissue perfusion, organ failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal Approach
Arm Type
Other
Arm Description
In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.
Arm Title
Restrictive Approach
Arm Type
Other
Arm Description
We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
Intervention Type
Drug
Intervention Name(s)
Vasopressors
Other Intervention Name(s)
phenylephrine, dopamine, norepinephrine, epinephrine, vasopressin
Primary Outcome Measure Information:
Title
MAP While on Vasopressors
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Who are receiving vasopressors for distributive shock Who are older than 16 years of age at the time of eligibility. Who are under the direct care of the ICU team regardless of location. 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. Who the treating physician believes will need vasopressors for at least 6 hours once enrolled. Exclusion Criteria: 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. 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). Have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss. Require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension. Who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension). If the attending team has agreed to withhold or withdraw life sustaining care. 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). Prior randomization in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Lamontagne, MD
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Queens Elizabeth II Hospital
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Mt Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Sunnybrooke HSC
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hopital L'Enfant-Jesus
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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Optimal VAsopressor titraTION Pilot Randomized Controlled Trial

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