Optimal VAsopressor titraTION Pilot Randomized Controlled Trial (OVATION)

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.

Study Overview

• Status: Completed
• Conditions: Shock; Hypotension
• Intervention / Treatment: Drug: Vasopressors

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queens Elizabeth II Hospital
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
    • Toronto, Ontario, Canada
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Mt Sinai Hospital
    • Toronto, Ontario, Canada
      • Sunnybrooke HSC
  • Quebec
    • Quebec City, Quebec, Canada
      • Hopital L'Enfant-Jesus
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Liberal Approach; In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.	Drug: Vasopressors; Other Names: phenylephrine; epinephrine; vasopressin; norepinephrine; dopamine
Other: Restrictive Approach; We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.	Drug: Vasopressors; Other Names: phenylephrine; epinephrine; vasopressin; norepinephrine; dopamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Francois Lamontagne
• Collaborators: Canadian Institutes of Health Research (CIHR); Fonds de la Recherche en Santé du Québec; Canadian Critical Care Trials Group
• Investigators: Principal Investigator: Francois Lamontagne, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: hypotension; organ failure; titration; vasopressors; tissue perfusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Cardiotonic Agents; Dopamine Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Hemostatics; Coagulants; Adrenergic beta-Agonists; Sympathomimetics; Mydriatics; Nasal Decongestants; Antidiuretic Agents; Adrenergic alpha-1 Receptor Agonists; Norepinephrine; Epinephrine; Dopamine; Vasopressins; Phenylephrine; Vasoconstrictor Agents
• Other Study ID Numbers: OVATION (Other Identifier: Alias Study Number)