NCT07414160

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

February 5, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 5, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

prealbuminCritically Ill PatientsPrognosis

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    Death from any cause occurring during the index ICU stay

    From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).

Secondary Outcomes (16)

  • In-hospital mortality

    From ICU admission (Day 1) through hospital discharge or death, whichever occurs first (up to 28 days).

  • ICU-acquired infection

    From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).

  • ICU length of stay

    From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).

  • Ventilator-free days through Day 28

    28 days after ICU admission

  • Vasopressor-free days during ICU stay

    From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).

  • +11 more secondary outcomes

Study Arms (1)

Critically ill adults admitted to the ICU

Age \> 18 years, SOFA score ≥ 2, and at least three prealbumin data points within the previous 14 days. Exclusion criteria: patients with liver failure, kidney failure, hereditary amyloidosis and Alzheimer's disease, long-term use of hormones, or NSAIDs.

Other: No Intervention: Observational Cohort

Interventions

No study-specific intervention is assigned. Participants receive usual clinical care as determined by the treating team

Critically ill adults admitted to the ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the ICU of Jilin University First Hospital.

You may qualify if:

  • age \> 18 years,
  • SOFA score ≥ 2
  • at least three prealbumin data points within the previous 14 days.

You may not qualify if:

  • patients with liver failure
  • patients with kidney failure,
  • hereditary amyloidosis and Alzheimer's disease
  • long-term use of hormones or NSAIDs. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • dong zhang

    The First Hospital of Jilin University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 17, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Because the research data contains potentially identifiable information, there is still a risk of re-identification even after de-identification; and due to ethical approval, institutional data management policies, and limitations on the scope of informed consent from participants, IPD will not be shared publicly at this time. The research results will be published in summary statistical form.