About this trial
Project Name: Improved Feeding Regimen for Critically Ill Patients (mNEED) Based on Feeding Intolerance Prediction Model Solution version number and version date: Version 5.0; 2024.12.16 Informed consent version number and version date: Version 1.0; 2023.10.19
Dear Patient, Recently, the department participated in a nationwide study to develop nutrition protocols for critically ill patients. Participation in a "Modified Feeding Regimen for Critically Ill Patients Based on a Predictive Model of Feeding Intolerance in Critically Ill Patients (mNEED): a multicenter, cohort randomized, controlled trial" is being invited. Before deciding whether to participate in the study, it is important to read the following information carefully to understand the clinical treatment study, its purpose, procedures, duration, and potential benefits, discomforts, and risks. If desired, the information can be discussed with relatives, friends, or the attending physician to assist in making an informed decision. For any questions, please direct them to the physician in charge of the study.
I. Introduction of Clinical Trials
Research Background and Purpose Leading international evidence-based guidelines consistently recommend early targeted nutritional therapy for critically ill patients. However, multicenter cluster-randomized controlled trials (cRCTs) evaluating the impact of implementing these guidelines have not demonstrated patient benefit. In 2022, Ke et al. proposed evidence-based Feeding Guidelines for Critically Ill Patients (NEED), which provided a specific feeding regimen for nutritional therapy in critically ill patients. The results suggested that the NEED group initiated enteral nutrition (EN) earlier and reduced the use of overall parenteral nutrition (PN). However, the NEED feeding strategies did not reduce the incidence of feeding intolerance in critically ill patients.
In previous studies, a predictive model of feeding intolerance (NOFI) in critically ill patients was constructed, demonstrating good predictive power. Therefore, the NEED feeding program will be improved (mNEED) based on NOFI to reduce the occurrence of feeding intolerance (FI) while ensuring the nutritional needs of critically ill patients are met.
Research Process
Research Funds: All treatment methods involved in this study follow conventional treatment procedures, without additional interventions or charges.
Study Content: This study is conducted by the Department of Intensive Care Medicine of the First Hospital of Jilin University, with 2,250 patients expected to be enrolled from ICUs in 90 hospitals nationwide. This study is a multicenter cluster randomized controlled trial, where each center is randomly divided into an experimental group and a control group. Data will be summarized and analyzed statistically.
Possible Risks This study involves an improvement in the feeding strategy for critically ill patients and will not cause additional risks. In the event of serious gastrointestinal adverse events, symptomatic management will be provided promptly.
Subject Benefits All participants in the study will be examined and treated by clinically experienced physicians, who will address questions and provide timely and thoughtful medical services. Participation may lead to improved conditions, and the results of this study may benefit other patients with similar conditions.
Voluntary Participation and Withdrawal Before the trial, a detailed understanding of the clinical trial is encouraged. The hospital and the attending physician are obligated to provide information related to the clinical trial and address any concerns. Participation in the clinical trial treatment is voluntary.
Duty of Confidentiality Medical records (including medical history, physical examination reports, and laboratory results) will be securely stored in the hospital. Access to these records will be limited to physicians (researchers), professional academic committees, ethics committees, and health supervision and management departments. Any public reporting of the study results will not disclose personal identities. Every effort will be made to protect the privacy of personal medical information to the extent permitted by law.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Feeding process
Procedure/SurgeryNutritional therapy is administered according to the feeding procedure
Treatment groups
Trial outcomes
Primary outcomes
Feeding intolerance
Intolerance to enteral feeding for any clinical reason (vomiting, high gastric residue, diarrhea, gastrointestinal bleeding, etc.). FI should be considered present if at least 20 kcal/kg BW/day via enteral route cannot be reached within 72 h of feeding attempt or if enteral feeding has to be stopped for whatever clinical reason. Vomiting: Any visible regurgitation of gastric contents, regardless of volume. High Gastric Residual Volume (GRV): GRV \> 200 mL per single measurement, assessed every 4 hours via syringe aspiration from the gastric/jejunal tube. Diarrhea: Three or more loose or liquid stools per day, with a stool weight greater than 200-250 g/day (or greater than 250 mL/day). Gastrointestinal Bleeding: Any bleeding within the gastrointestinal lumen, confirmed by visible blood in vomitus, gastric aspirate, or stool.
Secondary outcomes
Nutrition goal achievement
Proportion of Participants Achieving Nutritional Goals (Caloric Intake: 25 kcal/kg/day; Protein Intake: 1.3 g/kg/day) at Day 7 in the ICU Definition: The proportion of critically ill patients achieving at least 80% of their nutritional goals (caloric intake: 25 kcal/kg/day; protein intake: 1.3 g/kg/day) by Day 7 in the ICU. Nutritional intake will be calculated based on daily enteral and parenteral nutrition records, including calorie and protein intake data extracted from electronic medical records or nutrition monitoring tools.
28-day mortality rate
Death on the 28th day after ICU admission
90-day mortality
Death on the 90th day after ICU admission
SF-36 (Short Form-36 Health Survey)
SF-36 (Short Form-36 Health Survey) Score at Day 28 and Day 90 After ICU Admission Definition: The SF-36 is a widely used, patient-reported survey of health-related quality of life. It consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored on a scale of 0 to 100, with higher scores indicating better health status. The SF-36 score will be assessed at Day 28 and Day 90 after ICU admission.
Sponsors and contacts
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