Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-28 @ 12:41 PM
Study NCT ID:
NCT01587261
Status:
WITHDRAWN
Last Update Posted:
2019-03-06
First Post:
2012-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C for Severe Thermal Injuries
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries
Status:
WITHDRAWN
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: