An interventional study of For group Peds Sep A: Standard nutrition will be given and For Group Peds SepB: Low leucine, isoleucine formula in Pediatric Sepsis, sponsored by University of Pittsburgh. Not yet recruiting at 1 site in United States. Open to participants aged 44 Weeks to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
Sepsis is a leading global killer that occurs when an infection causes dysregulated and harmful immune, inflammation, and metabolism responses in children. These harmful responses differ on an individual basis from child to child both at presentation with sepsis and over time. In standard practice individual differences in metabolism of carbohydrate, protein and fat nutrition or food are not taken into account, with all children receiving the same 'one size fits all' nutritional formula. In pediatrics (but not adult medicine) there are physician specialists devoted to food metabolism who adjust the individual carbohydrate, protein, and fat components of the diet in children who develop 'metabolic crisis'. This metabolism specialty approach is presently reserved for children with inborn errors of metabolism who need specialized formulas lifelong. In the proposed project the investigators are asking whether the nutritional approaches used by pediatric metabolic specialists could be applied in a salutary manner to abnormal and harmful metabolism in children with sepsis. Because metabolism tests take a while to return (3-7 days), the investigators have used machine learning on 25 bedside clinical characteristics of children with sepsis at 24 hours to diagnose differences in metabolism in four groups of children we call Ped Sep A, B, C, and D. Compared to PedSep A children who are tolerant of sepsis, those who develop adverse outcomes have abnormal metabolism. PedSep B children have abnormal metabolism of branch chain amino acids a condition treated by metabolic specialists with formula restricted for these proteins. PedSep C children have dysregulated metabolism of fat a condition treated by metabolic specialists with supplementation of MCT oil. PedSepD children have abnormal metabolism of carbohydrate a condition treated by metabolic specialists with low carbohydrate high fat formula. Rather than give all children with sepsis the same nutritional formula, the investigators will give protein restricted formula to PedSep B children, MCT oil supplemented formula to PedSep C children, and low carbohydrate high fat formula to PedSep D patients. Because abnormal metabolism can change over time, the investigators will further also obtain blood and urine tests at admission and over the course of sepsis (acyl carnitine, amino acid and organic acid profiles) that the metabolic specialists will interpret to determine how to manage ongoing carbohydrate, protein, and fat nutrition in each patient. Using another machine learning approach the investigators will then identify causal association between earlier time to reaching sepsis tolerant metabolism, defined by normal branch chain amino acid, fatty acid, and carbohydrate metabolism; and, earlier time to resolution of organ failure and need for organ support therapies. When the project is completed in the investigator's single center the investigators will have taken an important step forward in being able to design new personalized nutrition randomized controlled multicenter trials to improve outcome in pediatric sepsis simply by giving personalized rather than 'one size fits all' nutrition.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 200 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria: Lack of commitment to PICU care by limiting aggressive or life-prolonging treatments
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).
Dietary Supplement: For group Peds Sep A: Standard nutrition will be given
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).
Dietary Supplement: For Group Peds SepB: Low leucine, isoleucine formula
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).
Dietary Supplement: For Group Peds Sep C: Medium chain triglyceride oil enriched formula.
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).
Dietary Supplement: For Group Peds Sep D: Low carbohydrate ketogenic formula
This intervention consists of the standard nutrition that is offered to patient's in the PICU
In this intervention instead of giving standard nutrition, a formula with low leucine and isoleucine will be given to patients in the PICU
In this group of subjects a formula that has medium chain triglyceride oil enrichment will be given to patients in the PICU
This group of subjects will receive a low carbohydrate, ketogenic formula in the PICU.
Organ failure free days.
The time in daysfor normalization for groups Peds Sep B, C and D to mirror the profile of Peds Sep A will be inversely causally associated with organ failure free days
Time frame: Subjects will be monitored for 28 days or until PICU discharge
Organ support free days
Time in days to B, C,and D metabolic profile normalization is inversely causally associated with organ support free days including need for mechanical ventilation, inotropes, vasopressors, CRRT, dialysis or ECMO
Time frame: Each child will be monitored for 28 days
Alive at 30 days
Subjects in groups Peds Sep B, C and D normalizing to Peds Sep A group metabolism is causally associated with survival at 30 days
Time frame: Subjects will be monitored for 30 days
Plan to share: No — All of the individual participant data collected during the trial may be shared with researchers after data deidentification. This data may include the study protocol, statistical analysis plan, informed consent and analytic code. The data will be available immediately after publication to any researchers who provide a methodologically sound protocol that is in line with this study's aims. This data will be available for an indefinite time by calling The University of Pittsburgh Office of Sponsored Programs at 412-624-7400. The data may be requested from the University of Pittsburgh Office of Sponsored Programs at 412-624-7400.
Start is estimated for Dec 2026; primary completion for Nov 2031, 59 months later.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 59 months is above that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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