Vitamin C for Severe Thermal Injuries

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01587261
First received: April 23, 2012
Last updated: January 12, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Severe Thermal Injury, Greater Than 20% TBSA
Drug: Vitamin C
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Fluid Volume Requirements during the resuscitative phase after severe burn [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Primary Outcome is to reduce fluid outcome requirements within the first 24 hours after severe thermal injury


Secondary Outcome Measures:
  • Days of Ventilator Support Required [ Time Frame: Hospital Course, estimated 6 weeks ] [ Designated as safety issue: No ]
    Comparisons between cohorts as to the number of days of ventilator support will be measured

  • Incidence of Abdominal Compartment Syndrome [ Time Frame: Hospital Course, estimated 6 weeks ] [ Designated as safety issue: No ]
  • Complication and infection rates in the Vitamin C group [ Time Frame: Hospital Course, estimated 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of Renal Failure [ Time Frame: Hospital Course, estimated 6 weeks ] [ Designated as safety issue: No ]
    Incidence of renal failure between cohorts will be measured


Estimated Enrollment: 54
Study Start Date: June 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587261

Contacts
Contact: Kareem R AbdelFattah, MD 2146482523 kareem.abdelfattah@phhs.org

Locations
United States, Texas
Parkland Memorial Hospital Not yet recruiting
Dallas, Texas, United States
Contact: Victoria Warren, RN    214-648-2523      
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     History of Changes
Other Study ID Numbers: KRA2012 
Study First Received: April 23, 2012
Last Updated: January 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Burns
Vitamin C
Thermal Injury
Fluid Resuscitation

Additional relevant MeSH terms:
Wounds and Injuries
Burns
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2016