Severe Thermal Injury, Greater Than 20% TBSAPhase 2NCT01587261
Vitamin C for Severe Thermal Injuries
A Phase 2 study testing Vitamin C in people with Severe Thermal Injury, Greater Than 20% TBSA, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Thermal Injury, Greater Than 20% TBSA
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2017to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries
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.
Read the 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.
- Being tested
- Vitamin C, Placebo
- Keywords
- Burns, Vitamin C, Thermal Injury, Fluid Resuscitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called High Dose Ascorbic Acid
Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury
PlaceboDrug
Also called LR
Lactated Ringers solution will be given at a similar volume to what the treatment group will receive
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Victims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours Receives: Drug: Placebo |
| Vitamin C | Experimental | Victims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (4)
Days of Ventilator Support Required
Comparisons between cohorts as to the number of days of ventilator support will be measured
Measured: Hospital Course, estimated 6 weeks
Incidence of Abdominal Compartment Syndrome
Measured: Hospital Course, estimated 6 weeks
Complication and infection rates in the Vitamin C group
Measured: Hospital Course, estimated 6 weeks
Incidence of Renal Failure
Incidence of renal failure between cohorts will be measured
Measured: Hospital Course, estimated 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Thermal Injury, Greater Than 20% TBSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kareem R AbdelFattah, MD, Principal investigator, UT-SouthwesternVictoria Warren, RN, Study director, UT-Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587261
- Sponsor's protocol ID
- KRA2012
- Status last verified
- Mar 2019
- First submitted
- 23 Apr 2012
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Placebo-Controlled Double-Blinded Trial for High-Dose Vitamin C Administration During the Acute Resuscitative Phase of Severe Thermal Injuries
- ClinicalTrials.gov ID
- NCT01587261
- Acronym / sponsor ID
- KRA2012
- Keywords
- Burns, Vitamin C, Thermal Injury, Fluid Resuscitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboVictims of severe thermal injury receiving placebo Lactated Ringers solution for the first 24 hours |
| Vitamin C | Experimental | Drug: Vitamin CVictims of severe thermal injury receiving high-dose vitamin C 66 mg/kg/hr for the first 24 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: High Dose Ascorbic AcidTreatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury | Drug | Vitamin C |
| PlaceboAlso: LRLactated Ringers solution will be given at a similar volume to what the treatment group will receive | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Days of Ventilator Support Required
Time frame: Hospital Course, estimated 6 weeks
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kareem R AbdelFattah, MD principal investigator
UT-Southwestern
Victoria Warren, RN study director
UT-Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C in people with Severe Thermal Injury, Greater Than 20% TBSA, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Volume Requirements during the resuscitative phase after severe burn (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.