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

NCT05612867 | Completed

• 1 other identifier: 20-49
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Mortality

  Survival within the first 28 days

  28 hours

• Infection rate

  The time frame of any clinically documented infections and when they occurred

  180 days

• 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

• Fluid Requirement

  Total fluid requirements in first 72 hours

  72 hours

Study Arms (2)

PO Vitamin C

Patients who got PO vitamin C

Dietary Supplement: Vitamin C

IV Vitamin C

Patients who got IV vitamin C

Dietary Supplement: Vitamin C

Interventions

Vitamin C DIETARY_SUPPLEMENT

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.

IV Vitamin C; PO Vitamin C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To evaluate PO vitamin C in burns of greater than 20% total body surface area compared to previous published studies utilizing high dose vitamin C in patients older than 18 years of age.

You may qualify if:

• 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

You may not qualify if:

• Total Body Surface Area Burns under 20%.

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (7)

• 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. doi: 10.1001/archsurg.1997.01430260056011.

  PMID: 9041919 BACKGROUND

• 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. doi: 10.1097/00004630-199705000-00018.

  PMID: 9169953 BACKGROUND

• May JM. How does ascorbic acid prevent endothelial dysfunction? Free Radic Biol Med. 2000 May 1;28(9):1421-9. doi: 10.1016/s0891-5849(00)00269-0.

  PMID: 10924860 BACKGROUND

• 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. doi: 10.1001/archpsyc.1995.03950240066012.

  PMID: 7492257 BACKGROUND

• Barbosa E, Faintuch J, Machado Moreira EA, Goncalves 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.

  PMID: 19692922 BACKGROUND

• 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.

  PMID: 31111241 BACKGROUND

• 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. doi: 10.1097/00004630-199311000-00007.

  PMID: 8300697 RESULT

MeSH Terms

Conditions

Burns; Ascorbic Acid Deficiency

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Aldin Malkoc, MD

  Arrowhead Regional Medical Center

  STUDY CHAIR

• David T Wong, MD

  Arrowhead Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 10, 2022
• Study Start: December 12, 2020
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)