Vitamin C for Severe Thermal Injuries

• ClinicalTrials.gov Identifier: NCT01587261
• Recruitment Status: Withdrawn
• First Posted: April 30, 2012
• Last Update Posted: March 6, 2019
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Severe Thermal Injury, Greater Than 20% TBSA	Drug: Vitamin C; Drug: Placebo	Phase 2

Detailed Description:

Subjects presenting within 6 hours of a severe thermal injury, defined as greater than 20% of their total body surface area, or their family members will be approached on admission to Parkland Memorial Hospital and informed of the study. Those electing to participate in the study will be randomized to receive either high-dose vitamin C (66mg/kg/hr for the first 24 hours, this dosage is based on prior human studies) in addition to the standard resuscitation algorithm (as per the Parkland Formula) or to a control group receiving only the standard resuscitation algorithm. These subjects will then be followed during their hospital course for fluid requirements, urine output, infectious complication rates, liver/renal failure rates, abdominal compartment syndrome rates, and outcomes such as ICU days, total hospital days, and mortality. All adverse events will be monitored by a data safety monitoring board. Currently this is a planned pilot study with a future multi-center study planned based on the results of the pilot. These studies will help determine if high-dose vitamin C can be a safe adjunct to acute fluid resuscitation in severely burned patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries
• Estimated Study Start Date: June 2017
• Estimated Primary Completion Date: June 2017
• Estimated Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Victims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours	Drug: Placebo; Lactated Ringers solution will be given at a similar volume to what the treatment group will receive; Other Name: LR
Experimental: Vitamin C; Victims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours	Drug: Vitamin C; Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury; Other Name: High Dose Ascorbic Acid

Outcome Measures

Primary Outcome Measures :

1. Fluid Volume Requirements during the resuscitative phase after severe burn [ Time Frame: 24 hours ]
   Primary Outcome is to reduce fluid outcome requirements within the first 24 hours after severe thermal injury

Secondary Outcome Measures :

1. Days of Ventilator Support Required [ Time Frame: Hospital Course, estimated 6 weeks ]
   Comparisons between cohorts as to the number of days of ventilator support will be measured
2. Incidence of Abdominal Compartment Syndrome [ Time Frame: Hospital Course, estimated 6 weeks ]
3. Complication and infection rates in the Vitamin C group [ Time Frame: Hospital Course, estimated 6 weeks ]
4. Incidence of Renal Failure [ Time Frame: Hospital Course, estimated 6 weeks ]
   Incidence of renal failure between cohorts will be measured

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects presenting more than 6 hours from the estimated time of injury
2. Known inclusion in another interventional clinical trial
3. 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)
4. Pregnant Subjects
5. Prisoners or Subjects Under Arrest
6. Subjects younger than 18 years of age or older than 65 years of age
7. Subjects with Baux Scores (Age plus % TBSA) greater than 120 (describing a non-survivable injury)
8. Subjects with any known allergy to components included in injectable ascorbic acid
9. Subjects with significant trauma burden (ISS > 15), including any open fracture, intracranial hemorrhage, or significant intra-abdominal injury.

Contacts and Locations

Locations

United States, Texas

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Kareem R AbdelFattah, MD; UT-Southwestern
• Study Director: Victoria Warren, RN; UT-Southwestern

More Information

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01587261
• Other Study ID Numbers: KRA2012
• First Posted: April 30, 2012
• Last Update Posted: March 6, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas Southwestern Medical Center:

Burns; Vitamin C; Thermal Injury; Fluid Resuscitation

Additional relevant MeSH terms:

Wounds and Injuries; Burns; Ascorbic Acid; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents