Multiple Organ FailurePhase 3NCT03968640
Efficacy of Coenzyme Q10 Supplementation on Multi-Organ Dysfunction in Severely Burned Patients
A Phase 3 study testing CoQ10 in people with Multiple Organ Failure, run by American Burn Association at 1 site in United States.
Trial summary
This multi-center prospective intervention study is designed to develop coenzyme Q10 (CoQ10) supplementation as a cost-effective adjunctive therapy for burn injury. The long-term goals of this project are to establish the beneficial effects of CoQ10 on multiple organ dysfunction and on the clinical and functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Organ Failure
- What is being tested?
- CoQ10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 17 Jul 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Burn patients with 20% or greater of total body surface area (TBSA) burn and equal to or less than 70% TBSA burn
- Capable of receiving routine oral, enteral nutrition, or a combination of routine oral and enteral nutrition
- Enrolled within 72 hours after burn injury
- Patient or legally authorized representative (LAR) who is capable of giving full informed consent
- Anticipated hospital stay: 2 weeks or more
Who cannot join
- Patients with liver disease (bilirubin greater than 3 or diagnosis of liver cirrhosis) at the time of admission, hyperthyroidism that currently requires treatment, diagnosis of chronic heart failure, chronic renal failure requiring hemodialysis, malignancy currently undergoing treatment, or history of cancer or hematological malignancy treatment within 5 years
- History of HIV or AIDS
- Presence of concurrent injuries apart from burn injury that may produce long-term disabilities (e.g., spinal cord injury, anoxic brain injury)
- Participation in another research study that may confound the results of this study in the opinion of the site principal investigator
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
This multi-center prospective intervention study is designed to develop coenzyme Q10 (CoQ10) supplementation as a cost-effective adjunctive therapy for burn injury. The long-term goals of this project are to establish the beneficial effects of CoQ10 on multiple organ dysfunction and on the clinical and functional outcomes of burn victims.
Read the detailed description
Burns represent one of the most excruciating and devastating battlefield injuries. Based on estimates reported in 2010, burn injuries account for 603,000 visits to US emergency departments and 50,000 hospital admissions each year. The annualized cost of these hospitalizations totals $1 billion. Despite recent advances in acute critical care, the damage that occurs to organs and systems (e.g., heart, liver, kidney, lung, and immune cells) in the sub-acute phase of severe burn injury remains a major challenge to achieving further reductions in mortality and improvements in the long-term clinical and functional outcomes of burn.
The treatment proposed in this study targets the mitochondria, organelles that are crucial for the survival and function of every cell type within the body. Known as the power plants of cells, the mitochondria generate energy and also function as critical regulators of cellular life, death, and inflammation. Burn injury damages the mitochondria in cells close to and distant from the injury site. This, in turn, complicates the patient's critical illness by causing multiple organ dysfunction. The mitochondria, therefore, pose a plausible potential target to further improve the clinical outcome of burn patients. Nonetheless, therapies that target the mitochondria have not yet been studied in burn patients.
CoQ10 is an essential nutrient that is vital to the function and integrity of the mitochondria. CoQ10 deficiency causes mitochondrial dysfunction and thereby induces dysfunction in multiple organs, including liver, heart, immune cells (i.e., white blood cells), brain, and muscle. In a pilot clinical study of CoQ10, we showed that burn injury causes CoQ10 deficiency, which is reversed by CoQ10 supplementation. In our preclinical study in mice, CoQ10 administration prevented mitochondrial damage, systemic inflammation, and metabolic dysfunction in burned animals, and improved survival and bacterial killing activity in animals with severe infection. Our data indicate that CoQ10 deficiency caused by burn injury may worsen the patient's clinical condition. Since CoQ10 supplementation is capable of reversing CoQ10 deficiency, which, in turn, may prevent mitochondrial damage and subsequent dysfunction of multiple organs, it is a plausible therapy for preventing mortality and promoting recovery in burn patients.
Two hundred ninety eligible burn patients admitted to any of the 15 military and civilian hospitals participating in this study will be enrolled within 48 hours after severe burn injury and randomly assigned to either CoQ10 (n=150) or Placebo (n=150) group. The safety and the efficacy of CoQ10 on multiple organ dysfunction and death, length of hospital stay, mitochondrial damage, and muscle wasting will be studied in comparison with Placebo.
- Conditions
- Multiple Organ Failure
- Being tested
- CoQ10, Placebo
- Keywords
- MODS
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Dietary supplement
Also called Ubiquinol
The intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition.
PlaceboDietary supplement
The intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition.
| Study group | Role | What they receive |
|---|---|---|
| CoQ10 group | Active comparator | The patients assigned to the CoQ10 group will receive the loading dose of CoQ10 (1,800 mg/day) for 4 weeks followed by the maintenance dose of CoQ10 (600 mg/day) for 8 weeks or until hospital discharge, whichever comes first. Receives: Dietary Supplement: CoQ10 |
| Placebo | Placebo comparator | Allocation-concealed placebo will be used as an appropriate control. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients in the mitigation of multi-organ dysfunction (MODS)
Evaluated by the number of the six events (i.e., renal, respiratory, cardiovascular and liver dysfunction, coagulopathy, and death
Measured: 12 weeks
Secondary outcomes (12)
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
The six individual organ systems comprising the MODS score and their times of occurrences.
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
The weighted composite score of the six constituents
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
The maximum total Sequential Organ Failure Assessment (SOFA) score
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
The maximum SOFA score for each organ
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
AUC of total SOFA score (score x days)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
AUC of SOFA score for each organ (score x days)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Delirium (CAM-ICU) (number of days)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Length of hospital stay (number of days)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Sepsis (Sepsis-3) (number of incidence)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Septic Shock (Sepsis-3) (number of incidence)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Plasma mitochondrial DNA (4 blood collections)
Measured: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
3-Methylhistidine (3-MH) and creatinine in urine (a biomarker of muscle wasting)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jul 2018 (estimated)
- Primary completion17 Jul 2020 (estimated)
- Study completion17 Jul 2020 (estimated)
Why it stopped: Sponsor terminated award
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter two-arm prospective, randomized, double-blind, placebo-controlled clinical trial. 290 eligible burn patients admitted to military/civilian hospitals to be enrolled within 48 hours after severe burn injury (20%-70% TBSA burn) \& randomly assigned to either CoQ10 (n=145) or Placebo (n=145) groups. Patients in the CoQ10 group to receive loading dose of CoQ10 (1,800 mg/day) for 4 weeks and then maintenance dose of CoQ10 (600 mg/day) for 8 weeks or until hospital discharge. Allocation-concealed placebo will be used as an appropriate control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herb Phelan, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968640
- Sponsor's protocol ID
- ABA-MCTG-0005
- Other IDs
- W81XWH-18-2-0030
- Status last verified
- Jul 2023
- First submitted
- 28 May 2019
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Coenzyme Q10 Supplementation on Multi-Organ Dysfunction in Severely Burned Patients
- ClinicalTrials.gov ID
- NCT03968640
- Acronym / sponsor ID
- ABA-MCTG-0005
- Conditions
- Multiple Organ Failure
- Keywords
- MODS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated award
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 17 Jul 2020 (estimated)
- Study completion
- 17 Jul 2020 (estimated)
- First posted
- 30 May 2019 (actual)
- 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.
This multi-center prospective intervention study is designed to develop coenzyme Q10 (CoQ10) supplementation as a cost-effective adjunctive therapy for burn injury. The long-term goals of this project are to establish the beneficial effects of CoQ10 on multiple organ dysfunction and on the clinical and functional outcomes of burn victims.
Detailed description
Burns represent one of the most excruciating and devastating battlefield injuries. Based on estimates reported in 2010, burn injuries account for 603,000 visits to US emergency departments and 50,000 hospital admissions each year. The annualized cost of these hospitalizations totals $1 billion. Despite recent advances in acute critical care, the damage that occurs to organs and systems (e.g., heart, liver, kidney, lung, and immune cells) in the sub-acute phase of severe burn injury remains a major challenge to achieving further reductions in mortality and improvements in the long-term clinical and functional outcomes of burn.
The treatment proposed in this study targets the mitochondria, organelles that are crucial for the survival and function of every cell type within the body. Known as the power plants of cells, the mitochondria generate energy and also function as critical regulators of cellular life, death, and inflammation. Burn injury damages the mitochondria in cells close to and distant from the injury site. This, in turn, complicates the patient's critical illness by causing multiple organ dysfunction. The mitochondria, therefore, pose a plausible potential target to further improve the clinical outcome of burn patients. Nonetheless, therapies that target the mitochondria have not yet been studied in burn patients.
CoQ10 is an essential nutrient that is vital to the function and integrity of the mitochondria. CoQ10 deficiency causes mitochondrial dysfunction and thereby induces dysfunction in multiple organs, including liver, heart, immune cells (i.e., white blood cells), brain, and muscle. In a pilot clinical study of CoQ10, we showed that burn injury causes CoQ10 deficiency, which is reversed by CoQ10 supplementation. In our preclinical study in mice, CoQ10 administration prevented mitochondrial damage, systemic inflammation, and metabolic dysfunction in burned animals, and improved survival and bacterial killing activity in animals with severe infection. Our data indicate that CoQ10 deficiency caused by burn injury may worsen the patient's clinical condition. Since CoQ10 supplementation is capable of reversing CoQ10 deficiency, which, in turn, may prevent mitochondrial damage and subsequent dysfunction of multiple organs, it is a plausible therapy for preventing mortality and promoting recovery in burn patients.
Two hundred ninety eligible burn patients admitted to any of the 15 military and civilian hospitals participating in this study will be enrolled within 48 hours after severe burn injury and randomly assigned to either CoQ10 (n=150) or Placebo (n=150) group. The safety and the efficacy of CoQ10 on multiple organ dysfunction and death, length of hospital stay, mitochondrial damage, and muscle wasting will be studied in comparison with Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter two-arm prospective, randomized, double-blind, placebo-controlled clinical trial. 290 eligible burn patients admitted to military/civilian hospitals to be enrolled within 48 hours after severe burn injury (20%-70% TBSA burn) \& randomly assigned to either CoQ10 (n=145) or Placebo (n=145) groups. Patients in the CoQ10 group to receive loading dose of CoQ10 (1,800 mg/day) for 4 weeks and then maintenance dose of CoQ10 (600 mg/day) for 8 weeks or until hospital discharge. Allocation-concealed placebo will be used as an appropriate control.
| Arm | Type | Receives |
|---|---|---|
| CoQ10 group | Active comparator | Dietary Supplement: CoQ10The patients assigned to the CoQ10 group will receive the loading dose of CoQ10 (1,800 mg/day) for 4 weeks followed by the maintenance dose of CoQ10 (600 mg/day) for 8 weeks or until hospital discharge, whichever comes first. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAllocation-concealed placebo will be used as an appropriate control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older
- Burn patients with 20% or greater of total body surface area (TBSA) burn and equal to or less than 70% TBSA burn
- Capable of receiving routine oral, enteral nutrition, or a combination of routine oral and enteral nutrition
- Enrolled within 72 hours after burn injury
- Patient or legally authorized representative (LAR) who is capable of giving full informed consent
Key exclusion criteria (6 listed)
- Patients with liver disease (bilirubin greater than 3 or diagnosis of liver cirrhosis) at the time of admission, hyperthyroidism that currently requires treatment, diagnosis of chronic heart failure, chronic renal failure requiring hemodialysis, malignancy currently undergoing treatment, or history of cancer or hematological malignancy treatment within 5 years
- History of HIV or AIDS
- Presence of concurrent injuries apart from burn injury that may produce long-term disabilities (e.g., spinal cord injury, anoxic brain injury)
- Participation in another research study that may confound the results of this study in the opinion of the site principal investigator
- Pregnant women
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 |
|---|---|---|
| CoQ10Also: UbiquinolThe intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition. | Dietary supplement | CoQ10 group |
| PlaceboThe intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition. | Dietary supplement | Placebo |
Primary outcome
Evaluate the efficacy of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients in the mitigation of multi-organ dysfunction (MODS)
Time frame: 12 weeks
Evaluated by the number of the six events (i.e., renal, respiratory, cardiovascular and liver dysfunction, coagulopathy, and death
12 secondary outcomes
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 weeks
Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.
Time frame: 12 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 20 Jul 2023.
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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.
Herb Phelan, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CoQ10 in people with Multiple Organ Failure, run by American Burn Association 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 6 inclusion and 6 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 20 Jul 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate the efficacy of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients in the mitigation of multi-organ dysfunction (MODS) (time frame: 12 weeks). 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 20 Jul 2023.