Vitamin C for Severe Thermal Injuries

NCT01587261 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: KRA2012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Animal and human data have supported the notion that administration of large doses of Vitamin C has beneficial effects on those subjects suffering from large burns. This effect may be due, in part, to the antioxidant and free-radical-scavenging properties of Vitamin C. These studies have demonstrated an improvement in urine output during resuscitation and reduced need for fluid volumes during resuscitation. In turn, these subjects demonstrated a reduction of wound edema, improved respiratory status (demonstrated by improvements in P:F ratios and reduced ventilator days), and no differences in terms of the possible complications of high-dose vitamin C administration between standard and treatment groups. The purpose of this study is to prospectively determine if Vitamin C can be safely used as an adjunctive treatment for patients suffering severe thermal injuries. High-dose vitamin C administered at a dose of 66mg/kg/hr during the acute phase of severe burn injuries will reduce fluid requirements in the first 48 hours after injury.

Conditions

Severe Thermal Injury, Greater Than 20% TBSA

Keywords

Burns; Vitamin C; Thermal Injury; Fluid Resuscitation

Outcome Measures

Primary Outcomes (1)

• Fluid Volume Requirements during the resuscitative phase after severe burn

  Primary Outcome is to reduce fluid outcome requirements within the first 24 hours after severe thermal injury

  24 hours

Secondary Outcomes (4)

• Days of Ventilator Support Required

  Hospital Course, estimated 6 weeks

• Incidence of Abdominal Compartment Syndrome

  Hospital Course, estimated 6 weeks

• Complication and infection rates in the Vitamin C group

  Hospital Course, estimated 6 weeks

• Incidence of Renal Failure

  Hospital Course, estimated 6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Victims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours

Drug: Placebo

Vitamin C

EXPERIMENTAL

Victims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours

Drug: Vitamin C

Interventions

Vitamin C DRUG

Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury

Also known as: High Dose Ascorbic Acid

Vitamin C

Placebo DRUG

Lactated Ringers solution will be given at a similar volume to what the treatment group will receive

Also known as: LR

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects presenting with second and/or third degree burns exceeding 20% total body surface area but not greater than 75% TBSA
• Age between 18 and 65 years of age
• Subject has provided full written informed consent prior to the performance of any study-related treatment or procedure

You may not qualify if:

• Subjects presenting more than 6 hours from the estimated time of injury
• Subjects with known significant comorbidities (Congestive Heart Failure, Myocardial Infarction within 6 months of admission, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease or Renal Impairment)
• Pregnant Subjects
• Prisoners or Subjects Under Arrest
• Subjects younger than 18 years of age or older than 65 years of age
• Subjects with Baux Scores (Age plus % TBSA) greater than 120 (describing a non-survivable injury)
• Subjects with any known allergy to components included in injectable ascorbic acid
• Subjects with significant trauma burden (ISS \> 15), including any open fracture, intracranial hemorrhage, or significant intra-abdominal injury.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kareem R AbdelFattah, MD

  UT-Southwestern

  PRINCIPAL INVESTIGATOR

• Victoria Warren, RN

  UT-Southwestern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 30, 2012
• Study Start: June 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (1)