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NCT Number: NCT07484126

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Kidney: chronic kidney disease stage 4 or 5;
  • 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.

Treatment and study plan

Primary outcomes

  1. ICU mortality

    Time frame: up to 24 months

Secondary outcomes

  1. Hospital mortality

    Time frame: up to 24 months

  2. Length of mechanical ventilation

    Time frame: up to 24 months

  3. Length of ICU stay

    Time frame: up to 24 months

  4. Length of hospital Stay

    Time frame: up to 24 months

  5. Incidence of hospital- acquired infections

    Time frame: up to 24 months

  6. Incidence of gastrointestinal intolerance

    Time frame: up to 24 months

    During enteral nutrition support in ICU

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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