Mitochondrial Energy Metabolism in Burns | NCT07643545

Studies
Mitochondrial Energy Metabolism in Burns

NCT07643545

Sponsor

Arkansas Children's Hospital Research Institute

Status

Recruiting

Last Update Posted

Jun 11, 2026Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Burn Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2023Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Aug 10, 2023

First Submission Date that Met QC Criteria

Jun 9, 2026

First Posted Date

Jun 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Name	Class
National Institute of General Medical Sciences (NIGMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to assess the impact of burn injury on cellular energetics in patients that have been admitted to the burn center at Arkansas Children's Hospital for burn care and require one or more procedures to clean, debride, and repair burn wounds will be eligible to participate in this study.

During the study, we will collect the following information:

General background information such as date of birth, height, weight, and other basic information.
Medical information, such as: basic medical information, details of burn injury, vital signs on the day of surgery, medicines you take during your stay, and some clinical tests.
Blood, urine, and tissue during surgeries you have during your stay.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

125Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Bioenergetics	Peripheral Blood Mononuclear Cell (PBMC) respiration	Through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Blood metabolics signatures	Peripheral Blood Mononuclear Cell (PBMC) respiration	Through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female
Ages 2 years to 80 years
Requiring hospital admission for burn care
All races
All ethnicities

Exclusion Criteria:

Age < 2 years
Under 10 kg in body mass
Age > 80 years
Active pregnancy
Unable to provide informed consent and no legal authorized representative present
Patient is considered moribund at the time of admission by the treating physician.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Up to 125 patients (2 years to 80 years old) will be enrolled in this study. We will recruit both males and females requiring hospital admission to the ACH burn unit for burn care.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Craig Porter, PhD	Contact	5013643340		cporter@uams.edu
Lily Cheak, B.S.	Contact	5013643340		lcheak@uams.edu

Overall Officials

Name	Affiliation	Role
Craig Porter, PhD	Arkansas Children's Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital	Recruiting	Little Rock	Arkansas	72202	United States

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Description

Blood will be collected to assess mitochondrial function in PBMC's as well as the levels of various metabolites, catechomlamines, cytokines and hormones. Blood samples may be stored for further metabolomic/lipidomic/proteomic analyses.

If a urinary catheter is placed for surgery, a urine sample (up to 100 ml) may be collected to assess catecholamine and metabolite levels.

During surgical procedures, we will collect any tissue removed from burn wounds as part of your surgery. This may include skin, adipose tissue and muscle.