Personalized Metabolic Nutrition for Sepsis
(PMNS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Joseph A Carcillo, MD
Principal Investigator
Children's Hospital Department of Critical Care Medicine
Christopher Horvat, MD
Principal Investigator
Children's Hospital of Pittsburgh, Department of Critical Care Medicine
Are You a Good Fit for This Trial?
This trial is for children with sepsis (a serious infection causing organ problems) whose parents give permission. Children are included if they have sepsis and need special nutrition based on their metabolism.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Low carbohydrate ketogenic formula
- Low leucine, isoleucine formula
- Medium chain triglyceride oil enriched formula
- Standard nutrition
Trial Overview
The study compares different personalized nutrition formulas: one high in certain fats, one standard, one low in specific proteins, and one low-carb/ketogenic. Nutrition is tailored to each child's metabolic needs until their metabolism normalizes.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Children in Peds Sep B have dys-regulated amino acid metabolism and will receive low protein (low branched chain amino acid) nutrition. Nutrition will subsequently be modified by metabolic specialists according to each patients metabolic profile. (Acylcarnitine, organic acids, and amino acid profiles).
Children with Peds Sep C have dis-regulated fatty acid oxidation with low beta hydroxy-butyrate and will be treated with MCT oil nutrition. Nutrition will subsequently be modified by metabolic specialists according to each patients metabolic profile. (Acylcarnitine, organic acids, and amino acid profiles).
Children with Peds Sep D have dis-regulated carbohydrate metabolism with increased lactate and pyruvate and decreased beta hydroxy-butyrate and will receive low carbohydrate ketogenic nutrition. Nutrition will subsequently be modified by metabolic specialists according to each patients metabolic profile. (Acylcarnitine, organic acids, and amino acid profiles).
In Peds Sep A children have normal metabolism and will receive standard nutrition. Nutrition will subsequently be modified by metabolic specialists according to each patients metabolic profile. (Acylcarnitine, organic acids, and amino acid profiles).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
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