mNEED: a Multicentre, Cluster-randomized, Controlled Trial

Официальное название

Modifying Feeding Protocols for Critically Ill Patients (mNEED) Based on a Predictive Model of Feeding Intolerance in Critically Ill Patients: a Multicentre, Cohorts Randomized, Controlled Trial

Обзор

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.

Вмешательства

• Процедура Feeding process
  Nutritional therapy is administered according to the feeding procedure

Первичные конечные точки

• Feeding intolerance [Срок оценки: Within 7 days in the ICU]

Вторичные конечные точки (12)

• Nutrition goal achievement [Срок оценки: ICU day 7]
• 28-day mortality rate [Срок оценки: Day 28 after ICU admission]
• 90-day mortality [Срок оценки: Day 90 after ICU admission]
• SF-36 (Short Form-36 Health Survey) [Срок оценки: Day 28 and 90 after ICU admission]
• EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) [Срок оценки: Day 28 and 90 after ICU admission]
• diaphragm thickness [Срок оценки: ICU day 7]
• quadriceps thickness [Срок оценки: ICU day 7]
• rectus femoris cross-sectional area [Срок оценки: ICU day 7]
• upper limb muscle thickness [Срок оценки: ICU day 7]
• New infection in ICU [Срок оценки: From 48 hours after ICU admission to ICU discharge, assessed up to 90 days]
• Length of ICU stay [Срок оценки: ICU stay]
• ventilator-free days [Срок оценки: ICU day 28]

Критерии участия

Критерии включения

Age 18 or older Failure of one or more organ systems within 24 hours of admission to the ICU (SOFA score ≥2) Expected to stay in ICU for more than 48 hours Inability to eat orally No EN taboo

ICU Selection Criteria:

ICU in Grade 2 or above hospitals ICU with the ability to carry out intensive care and monitor patient FI ICU type: emergency, medical, surgical, neurosurgical, or comprehensive ICU

Критерии исключения

Patients who have received EN treatment in the past three days AGI Level IV patients Receiving palliative care and expected to die within 48 hours Pregnancy Long-term use of steroids or other immunosuppressants Patients undergoing radiotherapy or chemotherapy for malignant diseases Participation in other clinical studies

ICU Exclusion Criteria:

ICU that refuses to participate in the study ICU that has not passed the ethical review Pediatric ICU

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The First Hospital of Jilin University — Changchun
• Jilin University, Chaoyang District, Changchun City, Jilin Province — Changchun

Публикации

• Wang Y, Li Y, Chen Y, Zhang Y, Feng X, Lv D, Chen Y, Bi X, Yu Y, Peng Y, Li H, Zhang D. Modifying feeding protocols in critically ill patients based on a predictive model of feeding intolerance: protocol for a multicenter cluster randomized controlled trial (the mNEED study). Front Med (Lausanne). 2025 Nov 6;12:1649983. doi: 10.3389/fmed.2025.1649983. eCollection 2025. PMID 41281994

Идентификаторы

NCT: NCT06827275 · mNEEDstudy2025 · 320.6750.2024-25-6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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