Pediatric SepsisPMNSNCT07910591
Personalized Metabolic Nutrition Sepsis Study
A study testing For group Peds Sep A: Standard nutrition will be given, For Group Peds SepB: Low leucine, isoleucine formula and For Group Peds Sep C: Medium chain triglyceride oil enriched formula. in people with Pediatric Sepsis, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 44 weeks to 17 years
- Conditions the study is for
- Pediatric Sepsis
- What is being tested?
- For group Peds Sep A: Standard nutrition will be given, For Group Peds SepB: Low leucine, isoleucine formula and For Group Peds Sep C: Medium chain triglyceride oil enriched formula.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 weeks to 17 years
- All sexes
- No healthy volunteers
- Child
- 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
Exclusion Criteria: 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15421
Joseph A Carcillo, MD, 412-692-6737, carcilloja@ccm.upm.edu
Rajesh Aneja, MD, 412-692-5163, anejar@upmc.edu
About this study
Official title: Personalized Metabolic Nutrition for Children With Sepsis
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.
Read the detailed description
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.
- Conditions
- Pediatric Sepsis
- Being tested
- For group Peds Sep A: Standard nutrition will be given, For Group Peds SepB: Low leucine, isoleucine formula, For Group Peds Sep C: Medium chain triglyceride oil enriched formula., For Group Peds Sep D: Low carbohydrate ketogenic formula
- Keywords
- metabolism and nutrition in pediatric sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For group Peds Sep A: Standard nutrition will be givenDietary supplement
This intervention consists of the standard nutrition that is offered to patient's in the PICU
For Group Peds SepB: Low leucine, isoleucine formulaDietary 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.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 formulaDietary supplement
This group of subjects will receive a low carbohydrate, ketogenic formula in the PICU.
| Study group | Role | What they receive |
|---|---|---|
| Peds Sep A: normal metabolism, standard nutrition | Sham comparator | 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). Receives: Dietary Supplement: For group Peds Sep A: Standard nutrition will be given |
| Peds Sep B: Dysregulated Branched Chain Amino Acid Metabolism: Low leucine, isoleucine formula | Active comparator | 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). Receives: Dietary Supplement: For Group Peds SepB: Low leucine, isoleucine formula |
| Peds Sep C: Dysregulated fat metabolism: Medium Chain Triglyceride Supplemented Formula | Active comparator | 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). Receives: Dietary Supplement: For Group Peds Sep C: Medium chain triglyceride oil enriched formula. |
| Peds Sep D: Dysregulated carbohydrate metabolism: Low carbohydrate ketogenic formula | Active comparator | 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). Receives: Dietary Supplement: For Group Peds Sep D: Low carbohydrate ketogenic formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Subjects will be monitored for 28 days or until PICU discharge
Secondary outcomes (1)
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
Measured: Each child will be monitored for 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric SepsisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Joseph Carcillo, University of Pittsburgh
- Investigators
- Joseph A Carcillo, MD, Principal investigator, Children's Hospital Department of Critical Care MedicineChristopher Horvat, MD, Principal investigator, Children's Hospital of Pittsburgh, Department of Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910591
- Sponsor's protocol ID
- STUDY26010055
- Other IDs
- R01GM108618
- Acronym
- PMNS
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Qin Y, Kernan KF, Fan Z, Park HJ, Kim S, Canna SW, Kellum JA, Berg RA, Wessel D, Pollack MM, Meert K, Hall M, Newth C, Lin JC, Doctor A, Shanley T, Cornell T, Harrison RE, Zuppa AF, Banks R, Reeder RW, Holubkov R, Notterman DA, Michael Dean J, Carcillo JA. Machine learning derivation of four computable 24-h pediatric sepsis phenotypes to facilitate enrollment in early personalized anti-inflammatory clinical trials. Crit Care. 2022 May 7;26(1):128. doi: 10.1186/s13054-022-03977-3.
PubMed 35526000
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Metabolic Nutrition for Children With Sepsis
- ClinicalTrials.gov ID
- NCT07910591
- Acronym / sponsor ID
- PMNS / STUDY26010055
- Conditions
- Pediatric Sepsis
- Keywords
- metabolism and nutrition in pediatric sepsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peds Sep A: normal metabolism, standard nutrition | Sham comparator | Dietary Supplement: For group Peds Sep A: Standard nutrition will be givenIn 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). |
| Peds Sep B: Dysregulated Branched Chain Amino Acid Metabolism: Low leucine, isoleucine formula | Active comparator | Dietary Supplement: For Group Peds SepB: Low leucine, isoleucine formulaChildren 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). |
| Peds Sep C: Dysregulated fat metabolism: Medium Chain Triglyceride Supplemented Formula | Active comparator | Dietary Supplement: For Group Peds Sep C: Medium chain triglyceride oil enriched 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). |
| Peds Sep D: Dysregulated carbohydrate metabolism: Low carbohydrate ketogenic formula | Active comparator | Dietary Supplement: For Group Peds Sep D: Low carbohydrate ketogenic formulaChildren 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). |
Who may qualify
- Ages
- 44 weeks to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| For group Peds Sep A: Standard nutrition will be givenThis intervention consists of the standard nutrition that is offered to patient's in the PICU | Dietary supplement | Peds Sep A: normal metabolism, standard nutrition |
| For Group Peds SepB: Low leucine, isoleucine formulaIn this intervention instead of giving standard nutrition, a formula with low leucine and isoleucine will be given to patients in the PICU | Dietary supplement | Peds Sep B: Dysregulated Branched Chain Amino Acid Metabolism: Low leucine, isoleucine formula |
| For Group Peds Sep C: Medium chain triglyceride oil enriched formula.In this group of subjects a formula that has medium chain triglyceride oil enrichment will be given to patients in the PICU | Dietary supplement | Peds Sep C: Dysregulated fat metabolism: Medium Chain Triglyceride Supplemented Formula |
| For Group Peds Sep D: Low carbohydrate ketogenic formulaThis group of subjects will receive a low carbohydrate, ketogenic formula in the PICU. | Dietary supplement | Peds Sep D: Dysregulated carbohydrate metabolism: Low carbohydrate ketogenic formula |
Primary outcome
Organ failure free days.
Time frame: Subjects will be monitored for 28 days or until PICU discharge
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
1 secondary outcome
Organ support free days
Time frame: Each child will be monitored for 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 35526000Qin Y, Kernan KF, Fan Z, Park HJ, Kim S, Canna SW, Kellum JA, Berg RA, Wessel D, Pollack MM, Meert K, Hall M, Newth C, Lin JC, Doctor A, Shanley T, Cornell T, Harrison RE, Zuppa AF, Banks R, Reeder RW, Holubkov R, Notterman DA, Michael Dean J, Carcillo JA. Machine learning derivation of four computable 24-h pediatric sepsis phenotypes to facilitate enrollment in early personalized anti-inflammatory clinical trials. Crit Care. 2022 May 7;26(1):128. doi: 10.1186/s13054-022-03977-3.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For group Peds Sep A: Standard nutrition will be given, For Group Peds SepB: Low leucine, isoleucine formula and For Group Peds Sep C: Medium chain triglyceride oil enriched formula. in people with Pediatric Sepsis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph A Carcillo, MD (412-692-6737 ext. x5164, carcilloja@ccm.upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ failure free days. (time frame: Subjects will be monitored for 28 days or until PICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.