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The Protective Effect of Ketogenic Diet on Organ Function in Sepsis Patients: A Multicenter Prospective Randomized Controlled Trial

The Protective Effect of Ketogenic Diet on Organ Function in Sepsis Patients: A Multicenter Prospective Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093805
Enrollment
Unknown
Registered
2024-12-12
Start date
2025-05-09
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

sepsis

Interventions

Intervention group:Patients in the intervention group will receive a ketogenic formula with 8g of carbohydrates per 100g.
Control group:The control group received Peptisorb enteral nutrition solution

Sponsors

Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >= 18 years; Meets the Sepsis 3.0 diagnostic criteria; Sepsis diagnosis within 72 hours at the time of enrollment; Enteral nutrition is feasible within 48 hours of ICU admission; Informed consent obtained from the patient or their guardian.

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding; Autoimmune diseases; Severe liver dysfunction or liver failure: Child-Pugh class C; Refractory metabolic acidosis: pH < 7.0 and persistent for more than 2 hours, difficult to correct; Presence of contraindications for enteral nutrition; Allergic to components of enteral nutrition.

Design outcomes

Primary

MeasureTime frame
Sequential Organ Failure Assessment;

Secondary

MeasureTime frame
ketone bodies;Intensive Care Unit Mortality Rate;Hospital mortality rate;Length of ICU stay;Length of hospital stay;Demand for vasoactive drugs;Mechanical ventilation rate;Duration of mechanical ventilation;lactate;glucose;Acute Physiology and Chronic Health Evaluation;levels of inflammatory cytokines;Acid-base balance;Rate of Continuous Renal Replacement Therapy;Duration of Continuous Renal Replacement Therapy;urine output per 24 hours.;

Countries

China

Contacts

Public ContactJiangquan Yu

Northern Jiangsu People's Hospital Affiliated to Yangzhou University

yujiangquan2021@163.com+86 180 5106 0659

Outcome results

None listed

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