EffectiveNess of feEding protocol on nutritional thErapy and clinical outcomes in critically ill patients: a multi-centered, cluster-ranDomized, parallel-controlled trial
Critically ill patients
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 (regional and tertiary) and ICU (emergency, medical, surgical, and general). Randomization will occur in a 1:1 fashion for the participating centers within the same category with computer-generated random numbers and all the randomization will be once completed. Allocation concealment was maintained by conducting randomization after consent to participate was obtained. Arm#1 feeding protocol group: Implementation of enteral nutrition feeding protocol. Arm#2 Control group: No adherence to uniform protocol and without any change to current clinical practice. _____ Previous interventions: Study participants are randomly allocated to one of two groups using cluster randomisation. Those in the first group receive the standardised feeding protocol. Participants are monitored closely for the occurrence of gastrointestinal adverse events and enteral feeding is adjusted in standardised way. The enteral feeding is standardized to accelerate the increment of enteral nutrition intake. The intervention is given for the whole ICU stay. Those in the second group receive the conventional enteral feeding protocol. They receive enteral feeding by the judgement of the treating physician and are not under the standardised protocol.
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
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