Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University
About this trial
Nutritional support therapy is a crucial part of ICU patient care, as both malnutrition and overnutrition can lead to adverse clinical outcomes. Meticulous monitoring of nutritional support is essential. Unfortunately, to date, there are no biomarkers available to assess the appropriateness of nutritional support in the ICU setting. However, mounting evidence suggests that phenotypic analysis of patients using nutritional biomarkers or risk screening scores for adaptation may enhance our ability to characterize patients in terms of prognosis and likelihood of treatment response.
This study aims to identify the trajectory patterns of prealbumin changes based on dynamic monitoring data of prealbumin during hospitalization of critically ill patients, and to analyze the Association between different trajectory groups and patient prognosis. In addition, this study will further analyze its Association with nutritional intake and nutritional indicators, thereby assessing the potential value of prealbumin change trajectories in terms of the adequacy and effectiveness of nutritional support for critically ill patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age > 18 years,
SOFA score ≥ 2
at least three prealbumin data points within the previous 14 days.
Disqualifiers
patients with liver failure
patients with kidney failure,
hereditary amyloidosis and Alzheimer's disease
long-term use of hormones or NSAIDs. -
Trial population
Patients admitted to the ICU of Jilin University First Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo study-specific intervention is assigned. Participants receive usual clinical care as determined by the treating team
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Critically ill adults admitted to the ICU1 intervention
Trial outcomes
Primary outcomes
1
ICU mortality
Death from any cause occurring during the index ICU stay
Time frame
From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).Secondary outcomes
1
In-hospital mortality
Death from any cause occurring during the index hospitalization.
Time frame
From ICU admission (Day 1) through hospital discharge or death, whichever occurs first (up to 28 days).2
ICU-acquired infection
New-onset infection occurring during the ICU stay (not present or incubating at ICU admission), diagnosed according to prespecified clinical and/or microbiological criteria.
Time frame
From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).3
ICU length of stay
Number of days from ICU admission to ICU discharge (or death in ICU), calculated in days.
Time frame
From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).4
Ventilator-free days through Day 28
Number of days alive and free from invasive mechanical ventilation from ICU admission through Day 28; patients who die before Day 28 are assigned 0 ventilator-free days.
Time frame
28 days after ICU admissionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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