Low Dose Vitamin C in Burns >20% Compared to Previous Studies With High Dose Vitamin C

Completed

• Conditions: Fluid and Electrolyte Imbalance; Ascorbic Acid Deficiency; Burn Degree Third; Burns; Burn Shock; Burn Degree Second
• Interventions: Dietary Supplement: Vitamin C

• Registration Number: NCT05612867
• Lead Sponsor: Arrowhead Regional Medical Center

Brief Summary

Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. As such, adequate fluid management and resuscitation is critical for burn patients to prevent further cellular injury. Technologies and medical options such as cardiac output monitoring along with early tube feeding and vitamin C administration have developed slowly over the years. Effective management of the Systemic Inflammatory Response Syndrome response and metabolic derangement is crucial for the survival of burn patients. In particular, vitamin C administration has shown to significantly decreases early post-burn lipid peroxidation, reduce microvascular leak of fluid by preventing endothelial dysfunction, and decreases edema formation in burned tissue. Vitamin C is a cheap and widely available antioxidant which has been shown to significantly effective in positively impacting clinical outcomes in burn resuscitation. We aim to evaluate the efficacy of vitamin C in burns greater than 20% total body surface area on clinical outcomes such as length of hospital stay, total fluid requirements, and mortality.

Detailed Description

Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. As such, adequate fluid management and resuscitation is critical for burn patients to prevent further cellular injury. Technologies and medical options such as cardiac output monitoring along with early tube feeding and vitamin C administration have developed slowly over the years. Effective management of the systemic inflammatory response syndrome response and metabolic derangement is crucial for the survival of burn patients. In particular, vitamin C administration has shown to significantly decreases early post-burn lipid peroxidation, reduce microvascular leak of fluid by preventing endothelial dysfunction, and decreases edema formation in burned tissue.

Vitamin C is a cheap and widely available antioxidant which has been shown to significantly effective in positively impacting clinical outcomes in burn resuscitation. While vitamin C is a regular part of burn resuscitation, there is no consensus on the most effective dose when considering impacting mortality, fluid resuscitation requirement, and other various clinical outcomes. Defining clinically efficacious minimal dosage of vitamin C can assist surgeons to better guide care for patients requiring burn resuscitation.

In this study, we aim to evaluate the efficacy of vitamin C in burns greater than 20% total body surface area on various clinical outcomes through a retrospective chart review of burn patients. Through this retrospective chart review, we aim to arrive at a better-defined vitamin C dose to achieve positive clinically significant outcomes.

Study Timeline

• Study Start: 2020-12-12
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Status Verified: 2022-10
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

All patients presenting to Arrowhead Regional Medical Center Emergency Department with International Classification of Diseases-10 codes of :

i. T31.2 Burns involving 20-29% of body surface ii. T31.3 Burns involving 30-39% of body surface iii. T31.4 Burns involving 40-49% of body surface iv. T31.5 Burns involving 50-59% of body surface v. T31.6 Burns involving 60-69% of body surface vi. T31.7 Burns involving 70-79% of body surface vii. T31.8 Burns involving 80-89% of body surface viii. T31.9 Burns involving 90% or more of body surface ix. T30.2 Burn of second degree, body region unspecified x. T30.3 Burn of third degree, body region unspecified

Exclusion Criteria

• Total Body Surface Area Burns under 20%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PO Vitamin C	Vitamin C	Patients who got PO vitamin C
IV Vitamin C	Vitamin C	Patients who got IV vitamin C

Primary Outcome Measures

Name	Time	Method
Infection rate	180 days	The time frame of any clinically documented infections and when they occurred
Mortality	28 hours	Survival within the first 28 days
Fluid Requirement	72 hours	Total fluid requirements in first 72 hours
Ventilator days	180 days	The total duration of time a patient spends intubated on a ventilator while in the hospital. The initial intubation will be the only intubation considered

Trial Locations

Locations (1)

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States