Early Glucose States and 72-Hour Care-Metabolic Clusters in Critically Ill Patients

NCT07851545 | Completed

• 1 other identifier: ICCA-GM-2026
• Study Type: observational
• Target: 5,109
• Locations: 1 country
• Sites: 1

Brief Summary

Blood glucose patterns during critical illness may change together with treatment, nutritional support, organ support, and the frequency of glucose monitoring. This retrospective observational study examines the relationship between glucose patterns identified during the first 24 hours of ICU care and broader care-metabolic patterns identified during the first 72 hours. The study evaluates how these early and later patterns relate to each other and whether the 72-hour clusters are associated with subsequent ICU mortality. The early glucose-state definition is also examined in MIMIC-IV as an external supportive analysis. No treatment or clinical intervention is assigned by the investigators.

Conditions

Hyperglycemia; Critical Illness

Keywords

Blood glucose; Glycemic variability; Critical illness; Intensive care unit; Cluster analysis; Metabolic-control pattern; Nutritional support; Organ support

Outcome Measures

Primary Outcomes (1)

• Subsequent ICU mortality after the 72-hour landmark

  Recorded all-cause ICU death occurring after completion of the 72-hour observation window among patients included in the locked 72-hour cluster cohort.

  From 72 hours after ICU admission until ICU discharge or recorded ICU death during the index ICU stay.

Other Outcomes (1)

• Cross-classification of 0-24-hour glucose states and 0-72-hour care-metabolic clusters

  First 72 hours after ICU admission

Study Arms (1)

Retrospective ICU cohort

Patients with eligible ICU stays in the institutional electronic health record source population. Nested subsets were used for 0-24-hour early glucose-state analysis and 0-72-hour integrated care-metabolic cluster analysis.

Other: Early glucose state; Other: 72-hour integrated care-metabolic cluster

Interventions

Early glucose state OTHER

Data-derived glucose state based on mean glucose, glucose coefficient of variation, and mean adjacent absolute glucose change during the first 24 hours after ICU admission. No exposure is assigned by investigators.

Retrospective ICU cohort

72-hour integrated care-metabolic cluster OTHER

Data-derived cluster based on glucose, glucose monitoring, documented insulin exposure, nutrition records, corticosteroid exposure, and organ-support variables recorded during the first 72 hours after ICU admission. Cluster membership is observational and is not assigned by investigators.

Retrospective ICU cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of ICU patients treated at a tertiary academic medical center whose electronic health record data were available for retrospective analysis. The reconstructed source population includes ICU stays lasting at least 24 hours. Early-state analyses additionally require at least five valid glucose measurements during the first 24 hours. The nested 72-hour cluster analysis is restricted to patients surviving and remaining observable through 72 hours with sufficient data to construct the complete prespecified feature set.

You may qualify if:

• Admission to one of the prespecified ICU units during the retrospective source-data period.
• Valid recorded ICU admission time.
• For the early glucose-state analysis: at least five valid glucose measurements during hours 0-24 after ICU admission.
• For the 72-hour cluster analysis: survival and continued observability through hour 72 and availability of the complete prespecified 26-feature cluster vector.

You may not qualify if:

• ICU stay shorter than 24 hours for the reconstructed source population.
• Insufficient valid glucose measurements for the early glucose-state analysis.
• Death, ICU discharge, or insufficient observation before completion of the 72-hour cluster window for the nested cluster analysis.
• Insufficient data to construct the prespecified 72-hour feature vector.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Critical Illness; Hyperglycemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: July 25, 2026
• Primary Completion: August 30, 2026
• Study Completion: August 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)