A Retrospective Clinical Study of Metabolic Status and Response to Nutritional Therapy in Patients With Mechanical Ventilation

March 17, 2026 updated by: Ling Liu, Southeast University, China
This study used a retrospective cohort study based on Multi-time longitudinal monitoring data were used to analyze the correlation mechanism between the dynamic evolution characteristics of nutrition-related biochemical indicators and individualized nutritional intervention in patients with mechanical ventilation. The inflammation-nutrition interaction model was constructed to correct the interference effect of inflammatory microenvironment on nutritional status assessment, so as to provide a basis for further achieving precision nutritional support.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the ICU

Description

Inclusion Criteria:

  • age ≥18 years old;
  • ICU admission ≥72 hours with invasive mechanical ventilation ≥24 hours;
  • start nutrition therapy within 72 hours after ICU admission and receive enteral or parenteral nutrition support for ≥3 days;
  • Relatively complete nutritional intervention records and nutrition-related biomarkers test results on the 1st, 3rd, and 7th (±1) days of ICU admission;

Exclusion Criteria:

  • women of childbearing age who have a positive pregnancy test, are pregnant or lactating;

  • chronic diseases with serious organ function damage or serious complications;

    1. Kidney: chronic kidney disease stage 4 or 5;
    2. Liver: previous history of liver failure, hepatic encephalopathy, or hepatic coma, gastrointestinal bleeding due to portal hypertension or Child-Pugh score ≥10 in recent years;
  • advanced malignant tumor, or chemotherapy or immunotherapy received within one month before admission;
  • severe immunodeficiency or current use of potent immunosuppressive agents, agranulocytosis (N<0.5×10^9/L), active hematologic malignancies or HIV stage III infection; Patients who were treated with immune-inducing drugs, such as antithymocyte globulin (ATG), antilymphocyte globulin (ALG), interleukin-2 receptor a chain antibody (IL-2RA), interleukin-6 receptor A antibody (IL-6RA); glucocorticoid therapy was continued for nearly 2 weeks, with a daily dose exceeding the hydrocortisone equivalent of 200mg;
  • critical illness, death in ICU within 1 week or palliative care only because death outcome was inevitable;
  • combined with severe or more severe burns: more than 30% of total body surface area burned or more than 10% of third-degree burn area; Or the total area is less than 30%, but the whole body condition is severe, or there are shock, combined injury, and respiratory tract burn.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients in the ICU received mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ICU mortality
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: up to 24 months
up to 24 months
Length of mechanical ventilation
Time Frame: up to 24 months
up to 24 months
Length of ICU stay
Time Frame: up to 24 months
up to 24 months
Length of hospital Stay
Time Frame: up to 24 months
up to 24 months
Incidence of hospital- acquired infections
Time Frame: up to 24 months
up to 24 months
Incidence of gastrointestinal intolerance
Time Frame: up to 24 months
During enteral nutrition support in ICU
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Metabolic status and nutrition

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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