Critical IllnessNCT07851545
Early Glucose States and 72-Hour Care-Metabolic Clusters in Critically Ill Patients
An observational study of Critical Illness and Hyperglycemia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Hyperglycemia
- What is being tested?
- Early glucose state and 72-hour integrated care-metabolic cluster
- How many people
- 5,109 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2026to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Admission to one of the prespecified ICU units during the retrospective source-data period.
- Valid recorded ICU admission time.
- Calculated ICU stay of at least 24 hours for inclusion in the reconstructed source population.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Early Glucose States and 72-Hour Integrated Care-Metabolic Clusters in Critically Ill Patients: A Retrospective Cohort Study
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.
Read the detailed description
This is a retrospective observational cohort study using electronic health record data from intensive care units at Zhongshan Hospital, Fudan University. Source clinical data were recorded from 2021 through 2025. The retrospective research study was initiated after institutional ethics approval in July 2026.
Two nested observation windows are evaluated. Early glucose states are derived from routinely recorded glucose data during the first 24 hours after ICU admission. The early-state features include mean glucose, coefficient of variation, and mean absolute change between adjacent glucose measurements. ICU stays used for early-state derivation require at least five valid glucose measurements during hours 0-24.
A second classification summarizes integrated care-metabolic information during the first 72 hours after ICU admission. The 72-hour cluster feature set contains 26 variables comprising glucose characteristics, monitoring intensity, documented insulin exposure, nutrition documentation and volume, corticosteroid exposure, mechanical ventilation, vasopressor use, and renal replacement therapy. Demographic variables, severity scores, microbiology variables, and outcomes are not used to derive the clusters.
The 0-24-hour glucose states and 0-72-hour integrated clusters are compared within ICU stays carrying both labels. Because the observation windows overlap, this comparison is interpreted as a nested-window cross-sectional mapping rather than a temporal transition between states.
Outcome follow-up for the cluster analysis begins after completion of the 72-hour landmark. The primary clinical outcome is subsequent ICU mortality. Associations between cluster membership and subsequent ICU mortality are estimated using logistic regression with adjustment for age, sex, and first-day SOFA score. Missing covariate data are examined using multiple-imputation sensitivity analyses, while missing ICU outcomes are examined using prespecified sensitivity bounds rather than outcome imputation.
Robustness analyses assess patient-disjoint reproducibility, bootstrap stability, dependence on explicit documentation-count variables, glucose-measurement interval, and chronic glycemic context. Cross-validated analyses assess whether the derived labels add predictive information beyond their continuous source variables.
The fixed institutional early-glucose-state transformation and centroids are projected without refitting to eligible MIMIC-IV ICU stays. This external analysis evaluates the direction of the early-state mortality gradient only and is not considered external validation of the four 72-hour clusters.
All glucose management, insulin use, nutritional support, organ support, microbiological testing, and antimicrobial treatment reflect routine clinical care. No exposure, glucose target, insulin regimen, nutritional intervention, or organ-support strategy is assigned by the investigators.
- Conditions
- Critical Illness, Hyperglycemia
- Being tested
- Early glucose state, 72-hour integrated care-metabolic cluster
- Keywords
- Blood glucose, Glycemic variability, Critical illness, Intensive care unit, Cluster analysis, Metabolic-control pattern, Nutritional support, Organ support
- Medical subject headings
- Critical Illness, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early glucose stateOther
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.
72-hour integrated care-metabolic clusterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early glucose state; Other: 72-hour integrated care-metabolic cluster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 72 hours after ICU admission until ICU discharge or recorded ICU death during the index ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start25 Jul 2026
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851545
- Sponsor's protocol ID
- ICCA-GM-2026
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level institutional data are not publicly available because they contain protected clinical information and are subject to institutional ethics and data-governance restrictions. MIMIC-IV data are independently available to credentialed users through PhysioNet.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Glucose States and 72-Hour Integrated Care-Metabolic Clusters in Critically Ill Patients: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07851545
- Acronym / sponsor ID
- ICCA-GM-2026
- Conditions
- Critical Illness, Hyperglycemia
- Keywords
- Blood glucose, Glycemic variability, Critical illness, Intensive care unit, Cluster analysis, Metabolic-control pattern, Nutritional support, Organ support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,109 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 25 Jul 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective observational cohort study using electronic health record data from intensive care units at Zhongshan Hospital, Fudan University. Source clinical data were recorded from 2021 through 2025. The retrospective research study was initiated after institutional ethics approval in July 2026.
Two nested observation windows are evaluated. Early glucose states are derived from routinely recorded glucose data during the first 24 hours after ICU admission. The early-state features include mean glucose, coefficient of variation, and mean absolute change between adjacent glucose measurements. ICU stays used for early-state derivation require at least five valid glucose measurements during hours 0-24.
A second classification summarizes integrated care-metabolic information during the first 72 hours after ICU admission. The 72-hour cluster feature set contains 26 variables comprising glucose characteristics, monitoring intensity, documented insulin exposure, nutrition documentation and volume, corticosteroid exposure, mechanical ventilation, vasopressor use, and renal replacement therapy. Demographic variables, severity scores, microbiology variables, and outcomes are not used to derive the clusters.
The 0-24-hour glucose states and 0-72-hour integrated clusters are compared within ICU stays carrying both labels. Because the observation windows overlap, this comparison is interpreted as a nested-window cross-sectional mapping rather than a temporal transition between states.
Outcome follow-up for the cluster analysis begins after completion of the 72-hour landmark. The primary clinical outcome is subsequent ICU mortality. Associations between cluster membership and subsequent ICU mortality are estimated using logistic regression with adjustment for age, sex, and first-day SOFA score. Missing covariate data are examined using multiple-imputation sensitivity analyses, while missing ICU outcomes are examined using prespecified sensitivity bounds rather than outcome imputation.
Robustness analyses assess patient-disjoint reproducibility, bootstrap stability, dependence on explicit documentation-count variables, glucose-measurement interval, and chronic glycemic context. Cross-validated analyses assess whether the derived labels add predictive information beyond their continuous source variables.
The fixed institutional early-glucose-state transformation and centroids are projected without refitting to eligible MIMIC-IV ICU stays. This external analysis evaluates the direction of the early-state mortality gradient only and is not considered external validation of the four 72-hour clusters.
All glucose management, insulin use, nutritional support, organ support, microbiological testing, and antimicrobial treatment reflect routine clinical care. No exposure, glucose target, insulin regimen, nutritional intervention, or organ-support strategy is assigned by the investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective ICU cohort | – | Other: Early glucose state, Other: 72-hour integrated care-metabolic clusterPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Admission to one of the prespecified ICU units during the retrospective source-data period.
- Valid recorded ICU admission time.
- Calculated ICU stay of at least 24 hours for inclusion in the reconstructed source population.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early glucose stateData-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. | Other | Retrospective ICU cohort |
| 72-hour integrated care-metabolic clusterData-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. | Other | Retrospective ICU cohort |
Primary outcome
Subsequent ICU mortality after the 72-hour landmark
Time frame: From 72 hours after ICU admission until ICU discharge or recorded ICU death during the index ICU stay.
Recorded all-cause ICU death occurring after completion of the 72-hour observation window among patients included in the locked 72-hour cluster cohort.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual-level institutional data are not publicly available because they contain protected clinical information and are subject to institutional ethics and data-governance restrictions. MIMIC-IV data are independently available to credentialed users through PhysioNet.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Hyperglycemia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subsequent ICU mortality after the 72-hour landmark (time frame: From 72 hours after ICU admission until ICU discharge or recorded ICU death during the index ICU stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.