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Vitamin C for Severe Thermal Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587261
Recruitment Status : Withdrawn (This potential study was held up at the level of the FDA as they wouldn't approve and IND for the dose of vitamin C we wanted to use.)
First Posted : April 30, 2012
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE April 23, 2012
First Posted Date  ICMJE April 30, 2012
Last Update Posted Date March 6, 2019
Estimated Study Start Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01587261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
  • 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
  • Incidence of Abdominal Compartment Syndrome [ Time Frame: Hospital Course, estimated 6 weeks ]
  • Complication and infection rates in the Vitamin C group [ Time Frame: Hospital Course, estimated 6 weeks ]
  • Incidence of Renal Failure [ Time Frame: Hospital Course, estimated 6 weeks ]
    Incidence of renal failure between cohorts will be measured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin C for Severe Thermal Injuries
Official Title  ICMJE Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Severe Thermal Injury, Greater Than 20% TBSA
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Lactated Ringers solution will be given at a similar volume to what the treatment group will receive
    Other Name: LR
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Victims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours
    Intervention: Drug: Placebo
  • Experimental: Vitamin C
    Victims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours
    Intervention: Drug: Vitamin C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 4, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2012)
54
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01587261
Other Study ID Numbers  ICMJE KRA2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kareem R AbdelFattah, MD UT-Southwestern
Study Director: Victoria Warren, RN UT-Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP