REVISE: re-evaluating the inhibition of stress erosions in the ICU—statistical analysis plan for a randomized trial. Heels-Ansdell, D., Billot, L., Thabane, L., Alhazzani, W., Deane, A., Guyatt, G., Finfer, S., Lauzier, F., Myburgh, J., Young, P., Arabi, Y., Marshall, J., English, S., Muscedere, J., Ostermann, M., Venkatesh, B., Zytaruk, N., Hardie, M., Hammond, N., Knowles, S., Saunders, L., Poole, A., Al-Fares, A., Xie, F., Hall, R., & Cook, D. Trials, 24(1):796, December, 2023.
REVISE: re-evaluating the inhibition of stress erosions in the ICU—statistical analysis plan for a randomized trial [link]Paper  doi  abstract   bibtex   
Abstract Background The REVISE ( R e- Ev aluating the I nhibition of S tress E rosions in the ICU) trial will evaluate the impact of the proton pump inhibitor pantoprazole compared to placebo in invasively ventilated critically ill patients. Objective To outline the statistical analysis plan for the REVISE trial. Methods REVISE is a randomized clinical trial ongoing in intensive care units (ICUs) internationally. Patients ≥ 18 years old, receiving invasive mechanical ventilation, and expected to remain ventilated beyond the calendar day after randomization are allocated to either 40 mg pantoprazole intravenously or placebo while mechanically ventilated. Results The primary efficacy outcome is clinically important upper GI bleeding; the primary safety outcome is 90-day mortality. Secondary outcomes are ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine concentration, and duration of mechanical ventilation, ICU, and hospital length of stay. Following an interim analysis of results from 2400 patients (50% of 4800 target sample size), the data monitoring committee recommended continuing enrolment. Conclusions This statistical analysis plan outlines the statistical analyses of all outcomes, sensitivity analyses, and subgroup analyses. REVISE will inform clinical practice and guidelines worldwide. Trial registration www.ClinicalTrials.gov NCT03374800. November 21, 2017.
@article{heels-ansdell_revise_2023,
	title = {{REVISE}: re-evaluating the inhibition of stress erosions in the {ICU}—statistical analysis plan for a randomized trial},
	volume = {24},
	issn = {1745-6215},
	shorttitle = {{REVISE}},
	url = {https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07794-z},
	doi = {10.1186/s13063-023-07794-z},
	abstract = {Abstract 
             
              Background 
               
                The REVISE ( 
                R 
                e- 
                Ev 
                aluating the 
                I 
                nhibition of 
                S 
                tress 
                E 
                rosions in the ICU) trial will evaluate the impact of the proton pump inhibitor pantoprazole compared to placebo in invasively ventilated critically ill patients. 
               
             
             
              Objective 
              To outline the statistical analysis plan for the REVISE trial. 
             
             
              Methods 
              REVISE is a randomized clinical trial ongoing in intensive care units (ICUs) internationally. Patients ≥ 18 years old, receiving invasive mechanical ventilation, and expected to remain ventilated beyond the calendar day after randomization are allocated to either 40 mg pantoprazole intravenously or placebo while mechanically ventilated. 
             
             
              Results 
               
                The primary efficacy outcome is clinically important upper GI bleeding; the primary safety outcome is 90-day mortality. Secondary outcomes are ventilator-associated pneumonia, 
                Clostridioides difficile 
                infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine concentration, and duration of mechanical ventilation, ICU, and hospital length of stay. Following an interim analysis of results from 2400 patients (50\% of 4800 target sample size), the data monitoring committee recommended continuing enrolment. 
               
             
             
              Conclusions 
              This statistical analysis plan outlines the statistical analyses of all outcomes, sensitivity analyses, and subgroup analyses. REVISE will inform clinical practice and guidelines worldwide. 
             
             
              Trial registration 
               
                www.ClinicalTrials.gov 
                NCT03374800. November 21, 2017.},
	language = {en},
	number = {1},
	urldate = {2024-05-30},
	journal = {Trials},
	author = {Heels-Ansdell, Diane and Billot, Laurent and Thabane, Lehana and Alhazzani, Waleed and Deane, Adam and Guyatt, Gordon and Finfer, Simon and Lauzier, François and Myburgh, John and Young, Paul and Arabi, Yaseen and Marshall, John and English, Shane and Muscedere, John and Ostermann, Marlies and Venkatesh, Bala and Zytaruk, Nicole and Hardie, Miranda and Hammond, Naomi and Knowles, Serena and Saunders, Lois and Poole, Alexis and Al-Fares, Abdulrahman and Xie, Feng and Hall, Richard and Cook, Deborah},
	month = dec,
	year = {2023},
	pages = {796},
}
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