Vitamin C for Severe Thermal Injuries
This study is not yet open for participant recruitment.
Verified April 2012 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01587261
First received: April 23, 2012
Last updated: April 30, 2012
Last verified: April 2012
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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: High Dose Ascorbic Acid 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 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Victims of severe thermal injury receiving placebo
|
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 vitamin C
|
Drug: High Dose Ascorbic Acid
Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury
Other Name: Vitamin C
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subjects presenting more than 6 hours from the estimated time of injury
- Known inclusion in another interventional clinical trial
- 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.
Contacts and Locations
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
No publications provided
| 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: | April 30, 2012 |
| 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:
|
Burns Wounds and Injuries Ascorbic Acid Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on October 17, 2012
