What this study is
Simplified from ClinicalTrials.govTesting a feeding plan matched to each child's own metabolism, with more or less carbohydrates, fats, or protein based on metabolic testing, to see whether it helps organ problems from sepsis (organ dysfunction caused by infection) go away, in children with sepsis from 44 weeks to 17 years old.
Read the original summary from ClinicalTrials.gov
Children with sepsis, a condition in which infection causes organ dysfunction will be enrolled with parental permission in this study. Nutrition will be given according to their individual metabolic profiles until normalization of metabolism. Metabolism is the way that children process food to meet our body's needs, based on metabolic testing the children may need more or less carbohydrates, more or less fats or more or less protein. The investigators will measure whether normalization of metabolism with this personalized nutrition leads to resolution of organ dysfunction.
What's being tested
- For group Peds Sep A: Standard nutrition will be given
Intervention · DIETARY SUPPLEMENT
This intervention consists of the standard nutrition that is offered to patient's in the PICU
- For Group Peds SepB: Low leucine, isoleucine formula
Intervention · DIETARY SUPPLEMENT
In this intervention instead of giving standard nutrition, a formula with low leucine and isoleucine will be given to patients in the PICU
- For Group Peds Sep C: Medium chain triglyceride oil enriched formula.
Intervention · DIETARY SUPPLEMENT
In this group of subjects a formula that has medium chain triglyceride oil enrichment will be given to patients in the PICU
- For Group Peds Sep D: Low carbohydrate ketogenic formula
Intervention · DIETARY SUPPLEMENT
This group of subjects will receive a low carbohydrate, ketogenic formula in the PICU.
Study details
- Official title
- Personalized Metabolic Nutrition for Children With Sepsis
- Sponsor
- University of Pittsburgh
- Conditions
- Pediatric Sepsis
- Enrolling
- 200 people
- Starts
- 2026-12-01
- Est. completion
- 2031-11-30
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 44 Weeks – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Inclusion Criteria: Age 44 weeks gestation and greater than 30 days after birth and less than 18 years old
- Diagnosed with sepsis and organ failure
You can't join if
- Lack of commitment to PICU care by limiting aggressive or life-prolonging treatments
- Limitation of life-sustaining treatments.
- Expectation of death in 48 hours as deemed by the clinical PICU attending.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Joseph A Carcillo, MD · Contact412-692-6737carcilloja@ccm.upm.edu
- Rajesh Aneja, MD · Contact412-692-5163anejar@upmc.edu
- Christopher M Horvat, Md · Principal investigator
Study team
Sponsor
University of Pittsburgh
Study ID STUDY26010055
Principal investigator
Joseph A Carcillo, MD
Children's Hospital Department of Critical Care Medicine
Principal investigator
Christopher Horvat, MD
Children's Hospital of Pittsburgh, Department of Critical Care Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.