Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jan 27, 2022
Date Accepted: Apr 14, 2022
Date Submitted to PubMed: Apr 14, 2022

The final, peer-reviewed published version of this preprint can be found here:

Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan

Adhikari NK, Pinto R, Day AG, Masse MH, Ménard J, Sprague S, Annane D, Arabi YM, Battista MC, Cohen D, Cook DJ, Guyatt GH, Heyland DK, Kanji S, McGuinness SP, Parke RL, Kumar Tirupakuzhi Vijayaraghavan B, Charbonney E, Chassé M, Del Sorbo L, Kutsogiannis DJ, Lauzier F, Leblanc R, Maslove DM, Mehta S, Mekontso Dessap A, Mele TS, Rochwerg B, Rewa OG, Shahin J, Twardowski P, Young PJ, Lamontagne F

Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan

JMIR Res Protoc 2022;11(5):e36261

DOI: 10.2196/36261

PMID: 35420994

PMCID: 9166642

Lessening Organ dysfunction with VITamin C (LOVIT): statistical analysis plan

  • Neill KJ Adhikari; 
  • Ruxandra Pinto; 
  • Andrew G Day; 
  • Marie-Hélène Masse; 
  • Julie Ménard; 
  • Sheila Sprague; 
  • Djillali Annane; 
  • Yaseen M Arabi; 
  • Marie-Claude Battista; 
  • Dian Cohen; 
  • Deborah J Cook; 
  • Gordon H Guyatt; 
  • Daren K Heyland; 
  • Salmaan Kanji; 
  • Shay P McGuinness; 
  • Rachael L Parke; 
  • Bharath Kumar Tirupakuzhi Vijayaraghavan; 
  • Emmanuel Charbonney; 
  • Michael Chassé; 
  • Lorenzo Del Sorbo; 
  • Demetrios James Kutsogiannis; 
  • Francois Lauzier; 
  • Remi Leblanc; 
  • David M Maslove; 
  • Sangeeta Mehta; 
  • Armand Mekontso Dessap; 
  • Tina S Mele; 
  • Bram Rochwerg; 
  • Oleksa G Rewa; 
  • Jason Shahin; 
  • Pawel Twardowski; 
  • Paul Jeffrey Young; 
  • François Lamontagne

ABSTRACT

Background:

Lessening Organ Dysfunction with VITamin C (LOVIT) is a blinded multicentre randomized clinical trial that compared 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:

To describe a pre-specified statistical analysis plan (SAP) for LOVIT, written 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% confidence interval in a generalized linear mixed model with binomial distribution and log link and considering site as a random effect. We will perform a secondary analysis adjusting for pre-specified 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 a SAP for the LOVIT trial and will adhere to it in the analysis phase. Clinical Trial: ClinicalTrials.gov identifier: NCT03680274 (21 September 2018)


 Citation

Please cite as:

Adhikari NK, Pinto R, Day AG, Masse MH, Ménard J, Sprague S, Annane D, Arabi YM, Battista MC, Cohen D, Cook DJ, Guyatt GH, Heyland DK, Kanji S, McGuinness SP, Parke RL, Kumar Tirupakuzhi Vijayaraghavan B, Charbonney E, Chassé M, Del Sorbo L, Kutsogiannis DJ, Lauzier F, Leblanc R, Maslove DM, Mehta S, Mekontso Dessap A, Mele TS, Rochwerg B, Rewa OG, Shahin J, Twardowski P, Young PJ, Lamontagne F

Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan

JMIR Res Protoc 2022;11(5):e36261

DOI: 10.2196/36261

PMID: 35420994

PMCID: 9166642

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.