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Completed

NCT Number: NCT01800877

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vasopressors

Drug

Other names: phenylephrine, dopamine, norepinephrine, epinephrine, vasopressin

Primary outcomes

  1. MAP While on Vasopressors

    Time frame: While on vasopressors from randomization until 28 days

    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).

Sponsors and collaborators

Lead sponsor

Francois Lamontagne

Other

Collaborators

  • Canadian Critical Care Trials Group
  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec

Registry information

Acronym: OVATION

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 28, 2013
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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