Clinical Trial Radar

28-Day All-Cause Mortality

Death from any cause occurring within 28 days of ICU admission. This is a binary outcome (alive or dead). Lower mortality indicates better outcome.

28 days after ICU admission

physical function score： EuroQol 5-Dimension 5-Level Questionnaire（EQ5D5L）

The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) is a standardized instrument for measuring health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels, and a visual analog scale (EQ-VAS) ranging from 0 to 100. The utility index score, calculated using the country-specific value set (e.g., China), typically ranges from \<0 (worse than death) to 1 (perfect health). Higher scores indicate better health status.

28 days after ICU admission，90 days after ICU admission，180 days after ICU admission，2 years after ICU admission

ICU Length of Stay

The number of days the patient remains in the intensive care unit (ICU), counted from the date of ICU admission to the date of ICU discharge. A higher number indicates longer ICU stay.

Duration of ICU stay, from admission to discharge from ICU up to 28 days

Serum Prealbumin Levels on Day 8, Day 28, Day 90, Day 180, and 2 Years

Serum prealbumin (transthyretin) concentrations will be measured at five time points (ICU day 8, day 28, and at 90 days, 180 days, and 2 years post-ICU admission). Venous blood samples will be used for laboratory analysis. Results will be reported in mg/dL. Higher levels indicate better nutritional status and recovery.

ICU day 8, day 28, and at 90 days, 180 days, and 2 years after ICU admission

Muscle Ultrasound Measurements on Day 8, Day 28, Day 90, Day 180, and 2 Years

Muscle mass will be assessed by bedside ultrasound at five time points: ICU day 8, day 28, and at 90 days, 180 days, and 2 years post-ICU admission. Parameters include diaphragm thickness, biceps thickness, quadriceps thickness, and rectus femoris cross-sectional area. Ultrasound measurements will follow standardized anatomical landmarks and positioning. Higher values reflect greater muscle mass and better nutritional status.

ICU day 8, day 28, and at 90 days, 180 days, and 2 years after ICU admission

Incidence of New Infections in the ICU

The number of patients who develop new infections during their ICU stay. Only infections acquired after ICU admission will be counted. Definitions follow CDC/NHSN surveillance criteria, including ventilator-associated pneumonia (VAP), catheter-related bloodstream infection (CRBSI), urinary tract infection (UTI), etc. This is a binary outcome (infection: yes/no) or count variable (number of new infections).

From ICU admission to ICU discharge up to 28 days

Ventilator-Free Days Within 28 Days After ICU Admission

The number of days within the first 28 days after ICU admission during which the patient is alive and free from invasive mechanical ventilation. If the patient dies within 28 days, the ventilator-free days will be counted as 0. Higher values indicate better outcomes.

28 days after ICU admission

All-Cause Mortality at Multiple Time Points (ICU, 28days，90 days, 180 days, 2 years)

All-cause mortality will be assessed at the following time points: during ICU stay, at 28 days, at 90 days, at 180 days, and at 2 years after ICU admission. Mortality status will be determined via hospital records or telephone follow-up. Lower mortality at each time point indicates better outcome.

From ICU admission to 2 years after ICU admission

The number of participants with Laboratory Safety Parameters and Liver Dysfunction

Laboratory parameters including blood glucose, blood lipids (total cholesterol, triglycerides), serum creatinine, blood urea nitrogen, and transaminases (ALT, AST) will be measured during ICU stay and up to day 28. Liver failure will be diagnosed based on clinical and laboratory criteria (e.g., jaundice, coagulopathy, elevated transaminases and bilirubin). These indicators are used to assess metabolic tolerance and organ function related to nutrition interventions.

From ICU admission to Day 28