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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients in the ICU received mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
ICU mortality
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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