NCT07643545

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

3.1 years

First QC Date

August 10, 2023

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Bioenergetics

    Peripheral Blood Mononuclear Cell (PBMC) respiration

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Blood metabolics signatures

    Through study completion, an average of 1 year

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Craig Porter, PhD

    Arkansas Children's Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig Porter, PhD

CONTACT

Lily Cheak, B.S.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

June 11, 2026

Study Start

April 20, 2023

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations