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| Name | Class |
|---|---|
| Canadian Critical Care Trials Group | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal Approach | Other | In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. |
|
| Restrictive Approach | Other | We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressors | Drug |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Lamontagne, MD | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital | St Louis | Missouri | 63141 | United States | ||
| University of Alberta Hospital |
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From April 2013 to August 2014, intensive care units (ICUs) at 11 academic hospitals in Canada and the USA participated in this open-label randomized controlled trial with approval from their local research ethics boards.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liberal Approach | In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors |
| FG001 | Restrictive Approach | We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Vasopressors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liberal Approach | In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors |
| BG001 | Restrictive Approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | mmHg | While on vasopressors from randomization until 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liberal Approach | In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg. Vasopressors |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie-Hélène Masse | Centre de Recherche du CHUS | 819-346-1110 | 14173 | marie-helene.masse3@usherbrooke.ca |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D012769 | Shock |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014662 | Vasoconstrictor Agents |
| D010656 | Phenylephrine |
| D004298 | Dopamine |
| D009638 | Norepinephrine |
| D004837 | Epinephrine |
| D014667 | Vasopressins |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Edmonton |
| Alberta |
| Canada |
| Queens Elizabeth II Hospital | Halifax | Nova Scotia | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| Mt Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Sunnybrooke HSC | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Hopital L'Enfant-Jesus | Québec | Quebec | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
Vasopressors
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 60 |
| 45 |
| 60 |
| EG001 | Restrictive Approach | We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg. Vasopressors | 0 | 60 | 41 | 60 |
| Myocardial injury | Cardiac disorders | Systematic Assessment |
|
| Bowel ischemia | Gastrointestinal disorders | Systematic Assessment |
|
| Digit or limb necrosis | Vascular disorders | Systematic Assessment |
|
| Gastric feeding intolerance | Gastrointestinal disorders | Systematic Assessment |
|
| Venous thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Major bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |