ISRCTN12233792
Completed
N/A
EffectiveNess of feEding protocol on nutritional thErapy and clinical outcomes in critically ill patients: a multi-centered, cluster-ranDomized, parallel-controlled trial
anjing Central Hospital0 sites2,772 target enrollmentNovember 24, 2017
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Critically ill patients
- Sponsor
- anjing Central Hospital
- Enrollment
- 2772
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36118758/ (added 20/09/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36314372 Secondary analysis (added 20/12/2023) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35767914/ Secondary analysis (added 20/12/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35172856 (added 20/12/2023) 2024 Results article in https://doi.org/10.1186/s13054-024-04813-6 post hoc analysis (added 22/01/2024)
Investigators
Eligibility 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 three days
- •Previous inclusion criteria:
- •1\. All patients expected to stay in ICU for over three days
- •2\. Aged 18 years and older
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
Outcomes
Primary Outcomes
Not specified
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