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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| The Physicians' Services Incorporated Foundation | OTHER |
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Commonly employed medications used in critically ill patients requiring life support include proton pump inhibitors (PPIs). These medications are thought to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite their widespread use, they do hold some risks which include infection in the form of pneumonia and diarrheal illnesses such as Clostridioides difficile infection (C. difficile). Emerging high-quality studies suggest PPI usage does not influence susceptibility to COVID-19 infection, however some studies suggest PPI use leads to poor outcomes in this population, including prolonged time on life-support and death. While we can appreciate the negative effects of PPI may be magnified in the sickest of patients, namely hospitalized patients with COVID-19, the beneficial or potentially harmful role they play in this population remains unclear.
We aim to build a clinical profile to further describe critically ill patients with COVID-19 in Ontario using the infrastructure of an ongoing multicenter clinical trial of acid suppression. We will identify characteristics that predict poor outcomes among sick COVID patients, examining the impact of PPIs on this population.
The overall aims are to further characterize the high-risk population of COVID-19 patients nested within the multicenter REVISE trial. Specifically, we plan 1) to explore the impact of PPIs on mechanically ventilated critically ill COVID-19 patients, 2) describe the clinical course for patients with COVID-19 and identify characteristics that predict poor prognosis, and 3) compare outcomes to patients without COVID-19. The overall research questions are as follows:
To accomplish this, the investigators propose to gather information in patients' medical charts including biomarkers drawn by the ICU team, venous thromboembolism (VTE) and tracheostomy timing, to link with extensive baseline characteristics and outcomes already collected in the REVISE trial (NCT03374800)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with COVID-19 |
| ||
| Patients without COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800) | Other | Following the intervention of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial (NCT03374800) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinically important gastro-intestinal bleeding | The primary efficacy outcome is clinically important GI bleeding occurring in the ICU or resulting in ICU readmission during the index hospital stay. The definition of clinically important GI bleeding is overt GI bleeding (i.e., hematemesis, frank blood or coffee ground nasogastric aspirate, melena or hematochezia) plus 1 of the following in the absence of other causes:
| 90 days |
| Primary Safety Outcome: 90 Day Mortality | Mortality status at day 90 post randomization | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-associated pneumonia | VAP is diagnosed in patients who received invasive mechanical ventilation for >48 hours when there is a new, progressive or persistent radiographic infiltrate plus at least 2 of the following without other obvious cause: 1) fever (temperature>38 °C) or hypothermia (temperature <36 °C); 2) leukopenia (<4.0x106/L) or leukocytosis (>12x106/L); 3) purulent sputum; or 4) gas exchange deterioration. |
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Inclusion Criteria:
Adults ≥18 years old projected to receive invasive mechanical ventilation for ≥48 hours according to the treating physician
Exclusion Criteria:
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Patients are eligible according to the inclusion and exclusion criteria of the REVISE trial, regardless of COVID status
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah J Cook, MD | Contact | 9055221155 | 35325 | debcook@mcmaster.ca |
| Nicole Zytaruk, RN | Contact | 9055221155 | 35325 | zytaruk@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Deborah Cook, MD | McMaster University | Principal Investigator |
| Brittany Dennis, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37644556 | Derived | Dennis BB, Thabane L, Heels-Ansdell D, Dionne JC, Binnie A, Tsang J, Guyatt G, Ahmed A, Lauzier F, Deane A, Arabi Y, Marshall J, Zytaruk N, Saunders L, Finfer S, Myburgh J, Muscedere J, English S, Ostermann M, Hardie M, Knowles S, Cook D; REVISE Investigators the Canadian Critical Care Trials Group. Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial. Trials. 2023 Aug 30;24(1):561. doi: 10.1186/s13063-023-07589-2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D006471 | Gastrointestinal Hemorrhage |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D012086 | Reoperation |
| D002986 | Clinical Trials as Topic |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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| 90 Days (while in ICU,censored at 90 days after randomization) |
| C. difficile infection | Defined as clinical features (diarrhea [>3 episodes of unformed stools or Bristol type 6 or 7), ileus, or toxic megacolon) and either microbiological evidence of toxin-producing C. difficile or pseudomembranous colitis on colonoscopy in hospital.](streamdown:incomplete-link) | 90 days (during the index hospital admission, censored at 90 days) |
| Renal replacement therapy | Defined as initiation of new renal replacement therapy in the ICU. | While in ICU,censored at 90 days after randomization |
| Hospital mortality | Defined as all-cause mortality in hospital. | While in hospital, censored at 90 days after randomization |
| Patient important GI bleeding | Defined as overt GI bleeding, plus an invasive intervention (e.g., therapeutic endoscopy, angiography, surgery), acknowledging how some clinically important GI bleeds in prior studies did not actually require any tests or treatments, and thus may not be important to patients. This outcome will be refined by an ongoing mixed methods study with an overarching instrument-building aim. | Censored at 90 days after randomization |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |