HypotensionOVATIONNCT01800877
Optimal VAsopressor titraTION Pilot Randomized Controlled Trial
A study testing Vasopressors in people with Hypotension and Shock, run by Francois Lamontagne at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Hypotension, Shock
- What is being tested?
- Vasopressors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Canada9 sites
University of Alberta Hospital
Edmonton, Alberta
Queens Elizabeth II Hospital
Halifax, Nova Scotia
Kingston General Hospital
Kingston, Ontario, K7L 2V7
The Ottawa Hospital
Ottawa, Ontario
Hopital L'Enfant-Jesus
Québec, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Mt Sinai Hospital
Toronto, Ontario, M5G 1X5
Sunnybrooke HSC
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypotension, Shock
- Being tested
- Vasopressors
- Keywords
- hypotension, vasopressors, titration, tissue perfusion, organ failure
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressorsDrug
Also called phenylephrine, dopamine, norepinephrine, epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Liberal Approach | Other | In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Receives: Drug: Vasopressors |
| Restrictive Approach | Other | We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Receives: Drug: Vasopressors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: While on vasopressors from randomization until 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francois Lamontagne
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
- Responsible party
- Sponsor-investigator, Francois Lamontagne, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Francois Lamontagne, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800877
- Sponsor's protocol ID
- OVATION
- Acronym
- OVATION
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2013
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Vasopressor Titration Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01800877
- Acronym / sponsor ID
- OVATION / OVATION
- Conditions
- Hypotension, Shock
- Keywords
- hypotension, vasopressors, titration, tissue perfusion, organ failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Francois LamontagneUniversity, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 12 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Approach | Other | Drug: VasopressorsIn the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. |
| Restrictive Approach | Other | Drug: VasopressorsWe will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressorsAlso: phenylephrine, dopamine, norepinephrine, epinephrine | Drug | Liberal Approach, Restrictive Approach |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Lamontagne, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasopressors in people with Hypotension and Shock, run by Francois Lamontagne at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP While on Vasopressors (time frame: While on vasopressors from randomization until 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.