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VItamin C in Thermal injuRY: The VICToRY Pilot Trial A feasibility study for a seamless adaptive phase II/III multi-center randomized trial

ClinicalTrials.gov Identifier: NCT04138394              

  
Background:

Worldwide, burn injuries represent a significant public health problem and are ranked the fourth most common injury. In certain disease states, such as those associated with severe burns and other critical illnesses, the relationship between nutrient deficiencies, altered immune status, and acquired infection has been recognized for many years. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death.

Consequently, over the last few decades numerous trials have evaluated the impact of different nutrition/nutrient strategies in critically ill patients and in particular, severe burns patients.

Recently, there has been renewed interest in the role of high dose intravenous vitamin C supplementation in critically ill patients and 4 Systematic Review and Metaanalysis (SR+MA) about this topic have been published in 2021, including one conducted by our own group, that indicated clinical meaningful effects on patients` survival. In our SR+MA published in Critical Care Medicine, we analyzed fifteen studies (n=2,490 ICU patients), our results shows that high-dose IV vitamin C monotherapy in critically ill patients is associated with improved overall mortality.1 Yet the origins of high dose vitamin C supplementation dates to research done more than 20 years ago in burn patients.2Today, few centers routinely administer high-dose vitamin C to severely burned patients, suggesting that a high level of evidence is warranted.

Major Objectives: We aim to conduct a large-scale, multi-center, randomized trial of high-dose intravenous vitamin C in severe burns worldwide. The purpose of the current proposal is to provide the rationale for a feasibility study that, if successful, will lead into a phase II/III multicentre adaptive randomized trial of supplemental intravenous vitamin C.

What are the principal research questions to be addressed in this feasibility pilot trial?

The primary goal of this first step is to determine the feasibility of the larger trial. Feasiblity ill be judged by a high degree of compliance with the study protocol (>90% compliance with study investigational product (IP), <5% Lost-to-Follow up [LTFU]), low amounts of consent failure (<30%), and adequate enrollment rates to support the larger confirmatory phase II/III trial. We will also use this feasibility pilot study to assess the distribution of ORP within treated and untreated burn patients. This will help us determine if ORP is a suitable primary outcome for the phase II part of the phase II/III trial and will provide estimates to support sample size determination of the confirmatory trial.
  

What are the principal research questions to be addressed in the pivotal Phase III trial?

Primary research question: In patients with severe, life-threatening burn injury, what is the effect of high dose (200mg/kg/day x 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC?

Secondary Research question: In patients with severe, life-threatening burn injury, what is the effect of high dose (200mg/kg/day x 96 hours) intravenous vitamin C in addition to SOC on time to discharge alive from hospital, hospital mortality, duration of stay in ICU and hospital, and 6-month mortality, health-related quality of life, and health care resources compared to add-on placebo and SOC?

Methods:  This pilot study will be conducted in 180 severe burn injury patients from 20 Burn Units worldwide, the VICToRY pilot will use the network of the current RE-ENERGIZE Trial, which was conducted in 60 Burn Units from 14 countries.  

Study Status: Sites in Canada, United States, Mexico, United Kingdom, Deutschland, and Belgium are in the start-up phase.

Funding: The study received funds from a Private Foundation and the Deutsch Research Foundation (STO1099/10-1).

The following Pharma companies are providing active intervention

Pharma Company

Country

WÖRWAG Pharma

Deutschland, Belgium 

McGuff Pharmaceuticals, Inc.

North America 

 

Contact Information

Research Project Leader:

Maureen Dansereau, Project Lead
Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 
Clinical Evaluation Research Unit 
Queen's University
Kingston, ON K7L 3N6
Canada

 

Contact Information for Deutschland:

Dr. rer. nat. Michael Melak

Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 

Telefon:+49 931 201-30130

Wissenschaftlicher Mitarbeiter, Deutschland

Principal Investigators: 

Drs. This email address is being protected from spambots. You need JavaScript enabled to view it. 1, Christian Stoppe 1, 2 and This email address is being protected from spambots. You need JavaScript enabled to view it.3  

  1. Clinical Evaluation Research Unit, Department of Critical Care Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, ON, Canada.
  2. University Hospital Wuerzburg, Deutschland.
  3. Medical Faculty RWTH Aachen, Aachen, Deutschland  

 

 References 

  1. Patel JJ, Ortiz-Reyes A, Dhaliwal R, et al. IV Vitamin C in Critically Ill Patients: A Systematic Review and Meta-Analysis. Crit Care Med. Sep 22 2021;doi:10.1097/CCM.0000000000005320
  2. Stoppe C, Lee ZY, Ortiz L, Heyland DK, Patel JJ. The Potential Role of Intravenous Vitamin C Monotherapy in Critical Illness. JPEN J Parenter Enteral Nutr. Jan 27 2022;doi:10.1002/jpen.2338

 

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