Hypotension Clinical Trial
— OVATIONOfficial title:
Optimal Vasopressor Titration Pilot Randomized Controlled Trial
NCT number | NCT01800877 |
Other study ID # | OVATION |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | February 2015 |
Verified date | February 2019 |
Source | Clinical Evaluation Research Unit at Kingston General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Francois Lamontagne | Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec |
United States, Canada,
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 |
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