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Systemic Biomarkers of Brain Injury From Hyperammonemia

NCT04602325 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2024-02-07

No results posted yet for this study

Summary

Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and developmental disabilities. The following aims are proposed:

Aim 1 of this study will be to determine the chronology of biomarkers of brain injury in response to a hyperammonemic (HA) brain insult in patients with an inherited hyperammonemic disorder.

Aim 2 will be to determine if S100B, NSE, and UCHL1 are altered in patients with two other inborn errors of metabolism, Maple Syrup Urine Disease (MSUD) and Glutaric Acidemia (GA1).

Conditions

  • Urea Cycle Disorder
  • Organic Acidemia
  • Maple Syrup Urine Disease
  • Glutaric Acidemia I
  • Fatty Acid Oxidation Disorder
  • Hypoxic-Ischemic Encephalopathy

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Nicholas Ah Mew, MD · Children's National Research Institute

  • Ljubica Caldovic, PhD · Children's National Research Institute

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2026-07-31
Completion
2027-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602325 on ClinicalTrials.gov