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

NCT07484126 | Not Yet Recruiting

• 1 other identifier: Metabolic status and nutrition
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  up to 24 months

Secondary Outcomes (6)

• Hospital mortality

  up to 24 months

• Length of mechanical ventilation

  up to 24 months

• Length of ICU stay

  up to 24 months

• Length of hospital Stay

  up to 24 months

• Incidence of hospital- acquired infections

  up to 24 months

Study Arms (1)

Patients in the ICU received mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-12