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

Burns Clinical Trial

Official title:

High Dose Intravenous Versus Low Dose Oral Vitamin C in Burn Care: Potential Protective Effects in the Severely Burned: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612867
• Other study ID #: 20-49
• Status: Completed
• Start date: December 12, 2020
• Est. completion date: January 8, 2021

Study information

• Verified date: October 2022
• Source: Arrowhead Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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%.

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Burn Degree Second
• Burn Degree Third
• Burn Shock
• Burns
• Fluid and Electrolyte Imbalance

Intervention

Dietary Supplement:
• Vitamin C
Due to clinical research supporting high dose vitamin C, the institution's surgical intensivists started utilizing a high IV vitamin C dose in higher total body surface area burns while continuing to use the standard PO vitamin C dose of 500 mg to 1,000 mg daily on patients with lower total body surface area burns. Looking at the initial 72 hours, patients with smaller burns were given 2,500 mg PO vitamin C and larger total body surface area burns were given 15,000 mg IV vitamin C.

Locations

Country	Name	City	State
United States	Arrowhead Regional Medical Center	Colton	California

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Barbosa E, Faintuch J, Machado Moreira EA, Gonçalves da Silva VR, Lopes Pereima MJ, Martins Fagundes RL, Filho DW. Supplementation of vitamin E, vitamin C, and zinc attenuates oxidative stress in burned children: a randomized, double-blind, placebo-controlled pilot study. J Burn Care Res. 2009 Sep-Oct;30(5):859-66. doi: 10.1097/BCR.0b013e3181b487a8. — View Citation

Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. — View Citation

Matsuda T, Tanaka H, Yuasa H, Forrest R, Matsuda H, Hanumadass M, Reyes H. The effects of high-dose vitamin C therapy on postburn lipid peroxidation. J Burn Care Rehabil. 1993 Nov-Dec;14(6):624-9. — View Citation

May JM. How does ascorbic acid prevent endothelial dysfunction? Free Radic Biol Med. 2000 May 1;28(9):1421-9. Review. — View Citation

Rock CL, Dechert RE, Khilnani R, Parker RS, Rodriguez JL. Carotenoids and antioxidant vitamins in patients after burn injury. J Burn Care Rehabil. 1997 May-Jun;18(3):269-78; discussion 268. — View Citation

Tanaka H, Matsuda H, Shimazaki S, Hanumadass M, Matsuda T. Reduced resuscitation fluid volume for second-degree burns with delayed initiation of ascorbic acid therapy. Arch Surg. 1997 Feb;132(2):158-61. — View Citation

Wang Y, Lin H, Lin BW, Lin JD. Effects of different ascorbic acid doses on the mortality of critically ill patients: a meta-analysis. Ann Intensive Care. 2019 May 20;9(1):58. doi: 10.1186/s13613-019-0532-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Survival within the first 28 days	28 hours
Primary	Infection rate	The time frame of any clinically documented infections and when they occurred	180 days
Primary	Ventilator 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	180 days
Primary	Fluid Requirement	Total fluid requirements in first 72 hours	72 hours