Skip to content

Time-restricted feeding in patients with sepsis

Time-restricted feeding in patients with sepsis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100992
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Time-restricted feeding group:Enteral feeding is performed daily from 5:00am to 5:00pm
Continuous feeding group:Feeding continued daily during the study period

Sponsors

Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old. 2. Meeting the diagnosis of sepsis, with the diagnostic criteria following the latest "Sepsis-3.0" standards established by the American College of Critical Care Medicine in 2016. 3. Anticipated mechanical ventilation for more than 72 hours (assessed by senior clinical doctors in the ICU). 4. Anticipated ICU stay of at least 7 days (assessed by senior clinical doctors in the ICU). 5. Sequential Organ Failure Assessment (SOFA) score >= 2. 6. Requiring nasogastric tube enteral nutrition. 7. Voluntarily participating in this study and signing the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, their legal guardian must act on their behalf in the informed consent process and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe liver dysfunction/liver failure (Child-Pugh score > 7 points / Class B). 2. Chronic kidney disease stage 5 (KDIGO stage 5). 3. Total pancreatectomy/insulin-dependent diabetes mellitus (IDDM). 4. Severe metabolic disorders (hospitalized for diabetic hyperosmolar coma/ketosis acidosis). 5. Refractory shock (norepinephrine infusion rate > 0.2 µg/kg/min, expected to deteriorate or die within 48 hours). 6. Patients requiring extracorporeal membrane oxygenation (ECMO) support. 7. Patients requiring hormone replacement therapy. 8. Contraindications to enteral nutrition or those who have received enteral nutrition for >= 12 hours before randomization. 9. Patients who refuse invasive rescue or those transferred from other ICUs. 10. Pregnant or lactating women. Vulnerable groups other than critically ill patients, including those with mental illness, cognitive impairment, illiteracy, etc.

Design outcomes

Primary

MeasureTime frame
30-day mortality;

Secondary

MeasureTime frame
Beta-hydroxybutyric acid levels;

Countries

China

Contacts

Public ContactWang Qianwen

Run Run Shaw Hospital, School of Medicine, Zhejiang University

21818174@zju.edu.cn+86 151 5716 8740

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026