ICU PatientsNCT07337798
Implementation of Clinical Nutrition Practice Guidelines in Surgical ICUs
A study testing Guideline Implementation in people with ICU Patients and Surgical, run by Xuanwu Hospital, Beijing.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients, Surgical, Nutrition Intervention
- What is being tested?
- Guideline Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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:
Show all 9Show fewer
- Diagnosed with brain death or awaiting organ donation
- Pregnant or breastfeeding women
- Concurrent participation in other nutrition-related clinical trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- ICU Patients, Surgical, Nutrition Intervention, Enteral Nutrition, Enteral Nutrition Intolerance
- Being tested
- Guideline Implementation
- Keywords
- Clinical Nutrition, Surgical Intensive Care Units, i-PARIHS Framework, Implementation Science, Clinical practice guideline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline ImplementationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Guideline Implementation Group | Experimental | 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. Receives: Behavioral: Guideline Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (prior to implementation) and at 6 months after implementation.
Secondary outcomes (1)
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.
Measured: From ICU admission (Day 1) to ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start20 Dec 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337798
- Sponsor's protocol ID
- iPARIHS-SICU-2025
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Implementing Evidence-Based Clinical Nutrition Practice Guidelines in Surgical Intensive Care Units: A Cohort Study
- ClinicalTrials.gov ID
- NCT07337798
- Acronym / sponsor ID
- iPARIHS-SICU-2025
- Conditions
- ICU Patients, Surgical, Nutrition Intervention, Enteral Nutrition, Enteral Nutrition Intolerance
- Keywords
- Clinical Nutrition, Surgical Intensive Care Units, i-PARIHS Framework, Implementation Science, Clinical practice guideline
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guideline Implementation Group | Experimental | Behavioral: Guideline ImplementationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Diagnosed with brain death or awaiting organ donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guideline ImplementationThis 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 | Behavioural | Guideline Implementation Group |
Primary outcome
Adherence of ICU Healthcare Professionals to Clinical Nutrition Practice Guidelines
Time frame: At baseline (prior to implementation) and at 6 months after implementation.
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.
1 secondary outcome
Proportion of Surgical Critically Ill Patients Achieving Energy and Protein Intake Targets During ICU Stay
Time frame: From ICU admission (Day 1) to ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for ICU Patients
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline Implementation in people with ICU Patients and Surgical, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ru Bin Han, Professor (+86 13701103033, hanbinru8723@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence of ICU Healthcare Professionals to Clinical Nutrition Practice Guidelines (time frame: At baseline (prior to implementation) and at 6 months after implementation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.