Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715567
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2023-02-03
Brief Title:
Re-EValuating the Inhibition of Stress Erosions REVISE - COVID-19 Cohort Study
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Re-EValuating the Inhibition of Stress Erosions REVISE - COVID-19 Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
1 Do critically ill patients projected to receive mechanical ventilation for 48 hours with COVID-19 have different clinical outcomes without PPIs
2 Are there prognostically relevant demographic biomarker and clinical data to characterize critically ill patients with COVID-19
3 Do critically ill patients with COVID-19 have significant higher rates of clinically important GI bleeding 90-day mortality and rates of infection when compared to a propensity-matched non-COVID REVISE cohort
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
1 Do critically ill patients projected to receive mechanical ventilation for 48 hours with COVID-19 have different clinical outcomes without PPIs
2 Are there prognostically relevant demographic biomarker and clinical data to characterize critically ill patients with COVID-19
3 Do critically ill patients with COVID-19 have significant higher rates of clinically important GI bleeding 90-day mortality and rates of infection when compared to a propensity-matched non-COVID REVISE cohort
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None