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Vitamin C for Severe Thermal Injuries

Primary Purpose

Severe Thermal Injury, Greater Than 20% TBSA

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Thermal Injury, Greater Than 20% TBSA focused on measuring Burns, Vitamin C, Thermal Injury, Fluid Resuscitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vitamin C

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Days of Ventilator Support Required
Comparisons between cohorts as to the number of days of ventilator support will be measured
Incidence of Abdominal Compartment Syndrome
Complication and infection rates in the Vitamin C group
Incidence of Renal Failure
Incidence of renal failure between cohorts will be measured

Full Information

First Posted
April 23, 2012
Last Updated
March 4, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01587261
Brief Title
Vitamin C for Severe Thermal Injuries
Official Title
Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Thermal Injury, Greater Than 20% TBSA
Keywords
Burns, Vitamin C, Thermal Injury, Fluid Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Victims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Victims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
High Dose Ascorbic Acid
Intervention Description
Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
LR
Intervention Description
Lactated Ringers solution will be given at a similar volume to what the treatment group will receive
Primary Outcome Measure Information:
Title
Fluid Volume Requirements during the resuscitative phase after severe burn
Description
Primary Outcome is to reduce fluid outcome requirements within the first 24 hours after severe thermal injury
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Days of Ventilator Support Required
Description
Comparisons between cohorts as to the number of days of ventilator support will be measured
Time Frame
Hospital Course, estimated 6 weeks
Title
Incidence of Abdominal Compartment Syndrome
Time Frame
Hospital Course, estimated 6 weeks
Title
Complication and infection rates in the Vitamin C group
Time Frame
Hospital Course, estimated 6 weeks
Title
Incidence of Renal Failure
Description
Incidence of renal failure between cohorts will be measured
Time Frame
Hospital Course, estimated 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kareem R AbdelFattah, MD
Organizational Affiliation
UT-Southwestern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Warren, RN
Organizational Affiliation
UT-Southwestern
Official's Role
Study Director
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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Vitamin C for Severe Thermal Injuries

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