ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimal Vasopressor Titration (OVATION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01800877
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : April 15, 2015
Sponsor:
Collaborators:
Canadian Critical Care Trials Group
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Francois Lamontagne, Clinical Evaluation Research Unit at Kingston General Hospital

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.

Condition or disease Intervention/treatment Phase
Hypotension Shock Drug: Vasopressors Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Vasopressor Titration Pilot Randomized Controlled Trial
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • Drugs classified as vasopressors in this study include catecholamines such as
  • phenylephrine, dopamine, norepinephrine, epinephrine and the pituitary hormone,
  • vasopressin. Pure inotropic agents such as dobutamine and milrinone will not
  • be considered as vasopressors.

Restrictive Approach
We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
Drug: Vasopressors
Other Names:
  • Drugs classified as vasopressors in this study include catecholamines such as
  • phenylephrine, dopamine, norepinephrine, epinephrine and the pituitary hormone,
  • vasopressin. Pure inotropic agents such as dobutamine and milrinone will not
  • be considered as vasopressors.




Primary Outcome Measures :
  1. Difference in the means of MAP while on vasopressors [ Time Frame: 2 years ]
    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 :
  1. Number of Protocol Violations [ Time Frame: 2 years ]
    We will capture the number of protocol violations, defined as a mean arterial pressure (MAP) consistently outside the permitted range for 4 consecutive hours or more while on vasopressors with no attempt to implement corrective measures.

  2. Number of Cross-overs [ Time Frame: 2 years ]
    We will quantify the number of cross-overs (patients whose mean arterial pressure corresponds to the target of the other arm for 8 consecutive hours while on vasopressors).

  3. Eligible patients not enrolled [ Time Frame: 2 years ]
    Number of eligible patients not enrolled.

  4. Time allowed in BP range while on vasopressors [ Time Frame: 2 years ]
    Time in allowed blood pressure range while on a continuous vasopressor infusion.

  5. Time with BP above/below allowed range [ Time Frame: 2 years ]
    Time with blood pressure above and below allowed range.


Other Outcome Measures:
  1. Tissue Perfusion [ Time Frame: 2 years ]
    Clinical endpoint - time to resolution of lactic acidosis within 28 days, censored for death as an early measure of treatment success

  2. Organ Function [ Time Frame: 2 years ]
    Clinical endopoint - time to resolution of every organ failure

  3. Complications of vasopressor use [ Time Frame: 2 years ]
    clinical endpoint - We plan to monitor complications of vasopressor use including the number of patients with cardiac arrhythmias, myocardial injury as detected by daily troponin levels, bowel ischemia requiring surgery, and digit necrosis.

  4. Important Interventions [ Time Frame: 2 years ]
    Duration and total amount of important interventions such as vasopressors, central venous catheters, arterial lines, intravenous fluid volumes, inotropes, corticosteroids, days in ICU will be recorded to describe overall resource use in each arm.

  5. Mortality [ Time Frame: 2 years ]
    Clinical endpoint - we will record ICU, Hospital and 6-month mortality.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800877


Locations
United States, Missouri
Mercy Hospital
St. Louis, Missouri, United States
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Nova Scotia
Queens Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
The Ottawa Hospital
Ottawa, Ontario, Canada
Mt Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sunnybrooke HSC
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hopital L'Enfant-Jesus
Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Francois Lamontagne
Canadian Critical Care Trials Group
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Francois Lamontagne, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Responsible Party: Francois Lamontagne, Assistant Professor, Universite de Sherbrooke, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01800877     History of Changes
Other Study ID Numbers: OVATION
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Francois Lamontagne, Clinical Evaluation Research Unit at Kingston General Hospital:
hypotension
vasopressors
titration
tissue perfusion
organ failure

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Norepinephrine
Vasoconstrictor Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents