Clinical trial NCT01587261: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Severe Thermal Injury, Greater Than 20% TBSA
Keywords: Burns
Vitamin C
Thermal Injury
Fluid Resuscitation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Fluid Volume Requirements during the resuscitative phase after severe burn
timeFrame: 24 hours
Secondary outcomes:
measure: Days of Ventilator Support Required
timeFrame: Hospital Course, estimated 6 weeks
measure: Incidence of Abdominal Compartment Syndrome
timeFrame: Hospital Course, estimated 6 weeks
measure: Complication and infection rates in the Vitamin C group
timeFrame: Hospital Course, estimated 6 weeks
measure: Incidence of Renal Failure
timeFrame: Hospital Course, estimated 6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT-Southwestern
name: Kareem R AbdelFattah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT-Southwestern
name: Victoria Warren, RN
role: STUDY_DIRECTOR
References: