Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan. Adhikari, N. K., Pinto, R., Day, A. G, Masse, M., Ménard, J., Sprague, S., Annane, D., Arabi, Y. M, Battista, M., Cohen, D., Cook, D. J, Guyatt, G. H, Heyland, D. K, Kanji, S., McGuinness, S. P, Parke, R. L, Tirupakuzhi Vijayaraghavan, B. K., Charbonney, E., Chassé, M., Del Sorbo, L., Kutsogiannis, D. J., Lauzier, F., Leblanc, R., Maslove, D. M, Mehta, S., Mekontso Dessap, A., Mele, T. S, Rochwerg, B., Rewa, O. G, Shahin, J., Twardowski, P., Young, P. J., Lamontagne, F., & LOVIT Investigators JMIR Research Protocols, 11(5):e36261, May, 2022.
Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan [link]Paper  doi  abstract   bibtex   
Background The LOVIT (Lessening Organ Dysfunction with Vitamin C) trial is a blinded multicenter randomized clinical trial comparing high-dose intravenous vitamin C to placebo in patients admitted to the intensive care unit with proven or suspected infection as the main diagnosis and receiving a vasopressor. Objective We aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database. Methods The SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses. Results The SAP includes a draft participant flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors, or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95% CI in a generalized linear mixed model with binomial distribution and log link, with site as a random effect. We will perform a secondary analysis adjusting for prespecified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status. Conclusions We have developed an SAP for the LOVIT trial and will adhere to it in the analysis phase. International Registered Report Identifier (IRRID) DERR1-10.2196/36261
@article{adhikari_lessening_2022,
	title = {Lessening {Organ} {Dysfunction} {With} {Vitamin} {C} ({LOVIT}) {Trial}: {Statistical} {Analysis} {Plan}},
	volume = {11},
	issn = {1929-0748},
	shorttitle = {Lessening {Organ} {Dysfunction} {With} {Vitamin} {C} ({LOVIT}) {Trial}},
	url = {https://www.researchprotocols.org/2022/5/e36261},
	doi = {10.2196/36261},
	abstract = {Background 
              The LOVIT (Lessening Organ Dysfunction with Vitamin C) trial is a blinded multicenter randomized clinical trial comparing high-dose intravenous vitamin C to placebo in patients admitted to the intensive care unit with proven or suspected infection as the main diagnosis and receiving a vasopressor. 
             
             
              Objective 
              We aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database. 
             
             
              Methods 
              The SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses. 
             
             
              Results 
              The SAP includes a draft participant flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors, or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95\% CI in a generalized linear mixed model with binomial distribution and log link, with site as a random effect. We will perform a secondary analysis adjusting for prespecified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status. 
             
             
              Conclusions 
              We have developed an SAP for the LOVIT trial and will adhere to it in the analysis phase. 
             
             
              International Registered Report Identifier (IRRID) 
              DERR1-10.2196/36261},
	language = {en},
	number = {5},
	urldate = {2024-05-30},
	journal = {JMIR Research Protocols},
	author = {Adhikari, Neill Kj and Pinto, Ruxandra and Day, Andrew G and Masse, Marie-Hélène and Ménard, Julie and Sprague, Sheila and Annane, Djillali and Arabi, Yaseen M and Battista, Marie-Claude and Cohen, Dian and Cook, Deborah J and Guyatt, Gordon H and Heyland, Daren K and Kanji, Salmaan and McGuinness, Shay P and Parke, Rachael L and Tirupakuzhi Vijayaraghavan, Bharath Kumar and Charbonney, Emmanuel and Chassé, Michaël and Del Sorbo, Lorenzo and Kutsogiannis, Demetrios James and Lauzier, François and Leblanc, Rémi and Maslove, David M and Mehta, Sangeeta and Mekontso Dessap, Armand and Mele, Tina S and Rochwerg, Bram and Rewa, Oleksa G and Shahin, Jason and Twardowski, Pawel and Young, Paul Jeffrey and Lamontagne, François and {LOVIT Investigators}},
	month = may,
	year = {2022},
	pages = {e36261},
}
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