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Effects of Implementing Evidence-Based Clinical Nutrition Practice Guidelines in Surgical Intensive Care Units: A Cohort Study
The goal of this interventional clinical trial is to evaluate whether the implementation of an evidence-based, context-adapted clinical nutrition practice guideline can improve clinical nutrition management in surgical intensive care units (ICUs) in China. The guideline is selected based on the best available evidence from existing surgical and critical care nutrition guidelines, adapted to the Chinese healthcare context, and implemented using an i-PARIHS-guided translation strategy. The trial involves ICU healthcare professionals working in surgical ICUs of tertiary general hospitals, while assessing nutrition-related clinical outcomes among surgical critically ill patients. The main questions it aims to answer are: Does guideline implementation improve ICU healthcare professionals' adherence to recommended clinical nutrition practice guidelines? Does the implementation of the clinical nutrition practice guideline improve the proportion of surgical critically ill patients who achieve recommended energy and protein intake targets during ICU stay? Researchers will compare outcomes before and after guideline implementation to determine whether the i-PARIHS-guided guideline translation improves nutrition management processes, healthcare professional performance, and patient-related clinical outcomes. Participants will: Complete baseline and post-implementation assessments related to clinical nutrition knowledge, attitudes, and practices. Participate in guideline-based education, training, and implementation activities guided by the i-PARIHS framework. Apply the adapted clinical nutrition practice guideline during routine clinical care in surgical ICUs. Be evaluated through on-site audits, questionnaires, and clinical data collection during the implementation process.
This study is an interventional, multicenter implementation clinical trial designed to translate and apply an evidence-based clinical nutrition practice guideline in surgical intensive care units (ICUs) in China, guided by the i-PARIHS framework. The guideline is developed through a structured process that includes identification of best available evidence from existing surgical and critical care nutrition guidelines, contextual adaptation to the Chinese healthcare setting, guideline item localization, and expert consensus validation. The implementation strategy is informed by the i-PARIHS framework, with particular emphasis on facilitation, local context assessment, and engagement of key stakeholders. A series of structured implementation activities, including education, training, on-site facilitation, audit and feedback, and continuous process optimization, are conducted to support guideline uptake in routine clinical practice. The implementation process follows a pre- and post-implementation design, allowing for comparison of outcomes before and after guideline translation. The primary outcomes focus on (1) adherence of ICU healthcare professionals to recommended clinical nutrition practice guidelines and (2) the proportion of surgical critically ill patients achieving recommended energy and protein intake targets during ICU stay. Secondary outcomes are assessed to comprehensively evaluate the impact of guideline implementation on nutrition delivery processes and patient-related clinical outcomes. These include: Timing of enteral nutrition initiation after ICU admission Frequency of enteral nutrition interruptions during ICU stay Global Leadership Initiative on Malnutrition (GLIM) classification at ICU discharge Cumulative daily energy and protein balance, including total caloric and protein surplus or deficit per day during ICU stay Laboratory indicators at ICU discharge, including urea-to-creatinine ratio, serum albumin, globulin, interleukin-6 (IL-6), and C-reactive protein (CRP) Length of ICU stay Clinical outcomes during ICU hospitalization All-cause 28-day mortality Data are collected through a combination of on-site clinical audits, standardized questionnaires, electronic medical record extraction, and laboratory testing. Outcomes related to healthcare professionals are measured using structured adherence assessment tools and knowledge-attitude-practice evaluations, while patient-related outcomes are derived from routinely collected clinical and laboratory data. The feasibility, appropriateness, and effectiveness of the guideline implementation are evaluated based on changes in outcome measures, process indicators, and participant satisfaction. The findings of this study are intended to inform scalable and context-sensitive strategies for optimizing clinical nutrition management in surgical ICUs within the Chinese healthcare system.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
December 20, 2025
Primary Completion Date
December 15, 2026
Completion Date
December 31, 2026
Last Updated
January 13, 2026
200
ESTIMATED participants
Guideline Implementation
BEHAVIORAL
Lead Sponsor
Xuanwu Hospital, Beijing
Collaborators
NCT06946290
NCT07466966
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07242196