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Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan.
Adhikari, Neill Kj; Pinto, Ruxandra; Day, Andrew G; Masse, Marie-Hélène; Ménard, Julie; Sprague, Sheila; Annane, Djillali; Arabi, Yaseen M; Battista, Marie-Claude; Cohen, Dian; Cook, Deborah J; Guyatt, Gordon H; Heyland, Daren K; Kanji, Salmaan; McGuinness, Shay P; Parke, Rachael L; Tirupakuzhi Vijayaraghavan, Bharath Kumar; Charbonney, Emmanuel; Chassé, Michaël; Del Sorbo, Lorenzo; Kutsogiannis, Demetrios James; Lauzier, François; Leblanc, Rémi; Maslove, David M; Mehta, Sangeeta; Mekontso Dessap, Armand; Mele, Tina S; Rochwerg, Bram; Rewa, Oleksa G; Shahin, Jason; Twardowski, Pawel; Young, Paul Jeffrey; Lamontagne, François.
  • Adhikari NK; Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
  • Pinto R; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
  • Day AG; Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
  • Masse MH; Kingston Health Sciences Centre, Kingston, ON, Canada.
  • Ménard J; Department of Public Health Sciences, Queen's University, Kingston, ON, Canada.
  • Sprague S; Research Centre of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
  • Annane D; Research Centre of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
  • Arabi YM; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
  • Battista MC; Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique - Hôpitaux de Paris [AP-HP]), Garches, France.
  • Cohen D; Institut National de la Santé et de la Recherche Médicale, Université Paris-Saclay Campus Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France.
  • Cook DJ; Fédération Hospitalo-Universitaire SEPSIS, Garches, France.
  • Guyatt GH; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
  • Heyland DK; King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Kanji S; Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • McGuinness SP; Department of Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada.
  • Parke RL; Bishop's University, Sherbroooke, QC, Canada.
  • Tirupakuzhi Vijayaraghavan BK; Massawippi Valley Foundation, Ayer's Cliff, QC, Canada.
  • Charbonney E; Department of Medicine, McMaster University, Hamilton, ON, Canada.
  • Chassé M; Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
  • Del Sorbo L; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
  • Kutsogiannis DJ; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
  • Lauzier F; Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
  • Leblanc R; Kingston General Health Research Institute, Kingston Health Sciences Centre, Kingston, ON, Canada.
  • Maslove DM; Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, ON, Canada.
  • Mehta S; The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
  • Mekontso Dessap A; Department of Pharmacy, The Ottawa Hospital, Ottawa, ON, Canada.
  • Mele TS; Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.
  • Rochwerg B; Medical Research Institute of New Zealand, Newtown, New Zealand.
  • Rewa OG; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
  • Shahin J; Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.
  • Twardowski P; Medical Research Institute of New Zealand, Newtown, New Zealand.
  • Young PJ; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.
  • Lamontagne F; School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
JMIR Res Protoc ; 11(5): e36261, 2022 05 20.
Article in English | MEDLINE | ID: covidwho-1862513
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.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Language: English Journal: JMIR Res Protoc Year: 2022 Document Type: Article Affiliation country: 36261

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Language: English Journal: JMIR Res Protoc Year: 2022 Document Type: Article Affiliation country: 36261