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Can a feeding protocol improve clinical outcomes in critically ill patients?

EffectiveNess of feEding protocol on nutritional thErapy and clinical outcomes in critically ill patients: a multi-centered, cluster-ranDomized, parallel-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12233792
Enrollment
2250
Registered
2017-11-24
Start date
2018-03-26
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Critically ill patients Injury, Occupational Diseases, Poisoning Critically ill patients

Interventions

Current interventions as of 15/01/2020: The R language will be used for randomization for this study. All the participating centers will be stratified according to the nature of its hospital (region

Sponsors

Nanjing Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 15/01/2020: 1. Informed consent form obtained from the patient or next of kin 2. Aged 18 years or older 3. Within 24 h of ICU admission 4. With one or more organ failure (SOFA for any single organ system=2) 5. Expected to stay in ICU more than 7 days 6. Oral diet is not likely to be restored within 3 days _____ Previous inclusion criteria: 1. All patients expected to stay in the ICU for over 3 days 2. Aged 18 years and older

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 15/01/2020: 1. Received EN in the past 3 days 2. Receiving palliative treatment or expected to die within 48 hours 3. Women in pregnancy 4. Long-term use of steroids or immunosuppressive agents 5. Patients with malignant diseases receiving radiotherapy or chemotherapy. _____ Previous exclusion criteria: 1. Subjects receiving EN in previous 7 days 2. Contraindications for nasogastric or nasoenteric tube placement 3. Subjects who have already undergone percutaneous endoscopic jejunostomy (PEJ), percutaneous endoscopic gastrostomy (PEG) and surgical jejunostomy 4. Age younger than 18 years old 5. Women who are pregnant or undergo breast feeding 6. Burn patients

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 15/01/2020: All-cause mortality at day 28 after randomization (the day of randomization will be set as day 1) _____ Previous primary outcome measure: 28-day mortality is measured using the vital status at 28 days after enrollment

Secondary

MeasureTime frame
Current secondary outcome measures as of 15/01/2020: Process measures: 1. Time to start EN 2. Time to start PN 3. Mean nutrition support days within the first 7 days after enrollment 3.1 Mean nutritional support (either EN or PN or both) days within the first 7 days after enrollment 3.2 Mean EN support days within the first 7 days after enrollment 3.3 Mean PN support days within the first 7 days after enrollment 4. Target-reaching rate of EN on day 3 and day 7 after enrollment 5. EN tolerance score in the first 7days after Enrollment 6. Days requiring prokinetic agents within the first 7 days after enrollment 7. Proportion of patients receiving PN prescription within the first 7 days after enrollment 8. Mean energy per day over the first 7 days for patients who were fed 9. Proportion of patients never fed during the first 7 days after enrollment 10. Proportion of patients fed within 24 h after enrollment 11. Mean energy delivered for patients who were fed within the first 7 days after enrollment 11.1 Mean energy delivered from EN within the first 7 days after enrollment 11.2 Mean energy delivered from PN within the first 7 days after enrollment 12. Proportion of patients who received a post-pyloric feeding tube (patients receiving EN) within the first 7 days after enrollment Organ dysfunction-related outcomes: 1. New onset organ failure within the first 7 days 1.1 New-onset respiratory failure; 1.2 New-onset cardiovascular failure; 1.3 New-onset renal failure 2. New receipt of organ support therapy within the first 7 days 2.1 New receipt of mechanical ventilation (non-invasive included) 2.2 New receipt of renal replacement therapy 2.3 New receipt of vasoactive agents 2.4 Days requiring CRRT within the first 7 days after enrollment 2.5 Days requiring insulin within the first 7 days after enrollment 2.6 Days requiring MV within the first 7 days after enrollment Additional outcomes: 1. Incidence of secondary infection in the ICU 2. Length of ICU stay _____ Previou

Countries

China

Contacts

Public ContactJuan Xing

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026