Implementation of Clinical Nutrition Practice Guidelines in Surgical ICUs

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ICU Patients; Enteral Nutrition; Nutrition Intervention; Surgical; Enteral Nutrition Intolerance
• Intervention / Treatment: Behavioral: Guideline Implementation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru Bin Han, Professor; Phone Number: +86 13701103033; Email: hanbinru8723@163.com
• Study Contact Backup: Name: Chen Xin, Mr.; Phone Number: +86 17863992191; Email: 1014974593@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For ICU healthcare professionals:

Employed at one of the participating study sites (tertiary general hospitals)

Holds a valid Registered Nurse license issued in the People's Republic of China

Currently working in frontline clinical nursing care in a surgical intensive care unit (ICU) during the study period

At least 1 year of clinical working experience

Able to understand the study objectives and procedures

Willing to participate and able to provide written informed consent

For surgical critically ill patients (outcome assessment population):

Aged 18 years or older

Admitted to a surgical ICU due to surgical-related conditions, including trauma, infection, malignancy, or postoperative complications

Expected length of stay in the surgical ICU of at least 48 hours

No restriction on sex

Patient or legally authorized representative able to provide written informed consent

Exclusion Criteria:

For ICU healthcare professionals:

Currently pregnant, breastfeeding, or planning pregnancy during the study period

Temporarily assigned, rotating, externally dispatched, on long-term training, or on leave during the study period, making continuous participation impossible

Participation in other interventional studies that may interfere with the implementation of this study

Determined by the research team to have cognitive, communication, or other conditions that would make participation inappropriate

For surgical critically ill patients:

Diagnosed with brain death or awaiting organ donation

Pregnant or breastfeeding women

Concurrent participation in other nutrition-related clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Guideline Implementation Group; Participants in this single-arm study will receive an evidence-based, context-adapted clinical nutrition practice guideline implemented in surgical intensive care units (ICUs) using an i-PARIHS-guided translation strategy. The implementation includes guideline localization, expert consensus validation, education and training, on-site facilitation, audit and feedback, and continuous process optimization. Outcomes will be assessed before and after guideline implementation to evaluate changes in healthcare professional adherence to clinical nutrition recommendations and nutrition-related clinical outcomes among surgical critically ill patients.

Behavioral: Guideline Implementation; This behavioral intervention consists of the implementation of an evidence-based, context-adapted clinical nutrition practice guideline in surgical intensive care units (ICUs), guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. The intervention includes systematic guideline selection based on existing surgical and critical care nutrition guidelines, contextual adaptation to the Chinese healthcare setting, guideline localization and expert consensus validation, and structured implementation strategies. Key components of the intervention include education and training of ICU healthcare professionals, on-site facilitation, audit and feedback, and continuous process optimization to support adherence to guideline recommendations. The intervention is delivered at the unit level and integrated into routine clinical practice in surgical ICUs. Outcomes are evaluated using a pre- and post-implementation design to assess changes in healt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence of ICU Healthcare Professionals to Clinical Nutrition Practice Guidelines	Adherence of ICU healthcare professionals to clinical nutrition practice guidelines, assessed using structured audit tools based on key guideline recommendations, including nutrition assessment, initiation and delivery of nutrition support, monitoring, and documentation practices.	At baseline (prior to implementation) and at 6 months after implementation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Surgical Critically Ill Patients Achieving Energy and Protein Intake Targets During ICU Stay	The proportion of surgical critically ill patients whose actual daily energy and protein intake meets guideline-recommended targets during ICU stay. Energy and protein intake will be calculated based on prescribed targets and recorded enteral and/or parenteral nutrition delivery. Patients achieving both energy and protein targets will be considered as meeting the outcome.	From ICU admission (Day 1) to ICU discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Initiation of Enteral Nutrition After ICU Admission	Time from ICU admission to the initiation of enteral nutrition, measured in hours, based on medical records and nutrition orders.	From ICU admission (Day 1) to initiation of enteral nutrition (up to 7 days).
Frequency of Enteral Nutrition Interruptions During ICU Stay	Number of enteral nutrition interruption events per patient during ICU stay, including interruptions due to procedures, intolerance, or clinical decisions, as documented in medical and nursing records.	From ICU admission (Day 1) to ICU discharge
GLIM Classification	Nutritional status at ICU admission and ICU discharge assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria, categorized according to standard GLIM diagnostic classifications.	At ICU admission (Day 1) and ICU discharge
Cumulative energy balance during ICU stay	Cumulative energy balance was calculated as the sum of the daily differences between delivered energy intake and prescribed energy targets during the ICU stay.	From ICU admission (Day 1) to ICU discharge
Cumulative protein balance during ICU stay	Cumulative protein balance was calculated as the sum of the daily differences between delivered protein intake and prescribed protein targets during the ICU stay.	From ICU admission (Day 1) to ICU discharge
Urea-to-Creatinine Ratio	Serum urea-to-creatinine ratio measured at ICU admission (Day 1) and ICU discharge, derived from routine laboratory testing.	At ICU admission (Day 1) and ICU discharge
Serum Albumin Levels	Serum albumin concentrations measured at ICU admission (Day 1) and ICU discharge based on routine laboratory tests.	At ICU admission (Day 1) and ICU discharge
Serum C-Reactive Protein (CRP) Level	The serum CRP level will be measured from blood samples collected at ICU admission (Day 1) and ICU discharge. CRP is an acute-phase protein that reflects systemic inflammation. The measurement will be performed using standard laboratory methods available at the hospital laboratory. Data will be reported in mg/L.	At ICU admission (Day 1) and ICU discharge
Length of ICU Stay	Duration of ICU hospitalization, measured in days from ICU admission to ICU discharge.	From ICU admission (Day 1) to ICU discharge
Clinical Outcomes During ICU Stay	Clinical outcomes during ICU stay, including occurrence of major complications and need for advanced organ support, extracted from electronic medical records.	From ICU admission(Day 1) to ICU discharge
All-Cause 28-Day Mortality	All-cause mortality within 28 days after ICU admission, determined from hospital records and follow-up data.	Up to 28 days after ICU admission

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Implementation Science; Clinical Nutrition; Clinical practice guideline; i-PARIHS Framework; Surgical Intensive Care Units
• Other Study ID Numbers: iPARIHS-SICU-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. The study involves sensitive clinical and professional information collected from ICU healthcare professionals and critically ill patients, and the data are derived from routine clinical records across multiple centers. Due to privacy protection, data confidentiality requirements, and institutional data governance policies, individual-level data cannot be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No