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

Sponsor
Arrowhead Regional Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05612867
Collaborator
(none)
54
1
27
60.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin C

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 Design

Study Type:
Observational
Actual Enrollment :
54 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Dec 12, 2020
Actual Primary Completion Date :
Jan 8, 2021
Actual Study Completion Date :
Jan 8, 2021

Arms and Interventions

Arm Intervention/Treatment
PO Vitamin C

Patients who got PO vitamin C

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.

IV Vitamin C

Patients who got IV vitamin C

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.

Outcome Measures

Primary Outcome Measures

  1. Mortality [28 hours]

    Survival within the first 28 days

  2. Infection rate [180 days]

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

  3. 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

  4. Fluid Requirement [72 hours]

    Total fluid requirements in first 72 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

All patients presenting to Arrowhead Regional Medical Center Emergency Department with

International Classification of Diseases-10 codes of :
  1. 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%.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arrowhead Regional Medical Center Colton California United States 92324

Sponsors and Collaborators

  • Arrowhead Regional Medical Center

Investigators

  • Study Chair: Aldin Malkoc, MD, Arrowhead Regional Medical Center
  • Principal Investigator: David T Wong, MD, Arrowhead Regional Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Arrowhead Regional Medical Center
ClinicalTrials.gov Identifier:
NCT05612867
Other Study ID Numbers:
  • 20-49
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2022