Development of an ICU Physiological State Space Monitor Based on the ICCA Database: A Single-Center Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60,000
- 试验地点
- 1
- 主要终点
- Composite Clinical Deterioration Within 72 Hours
研究概览
简要总结
Critically ill patients can deteriorate rapidly across multiple organ systems. Most intensive care unit (ICU) risk tools rely on measurements collected at a single time point and may not fully capture how physiology evolves or how quickly a patient recovers from disturbance. This single-center retrospective observational study will use routinely collected data from the ICCA reporting database at Zhongshan Hospital, Fudan University to develop and internally validate a research prototype called the ICU Physiological State Space Monitor. Adult ICU admissions will be represented as daily state vectors across 10 physiological domains. The study will characterize each patient's position and movement in a multidimensional state space, identify high-risk regions and possible critical transitions, and quantify physiological resilience using trajectory features such as variability, autocorrelation, curvature, recovery slope, and cross-domain coupling. The primary validation outcome is a composite clinical deterioration event within 72 hours after an eligible index patient-day. The monitor is an analytic and visualization framework for retrospective research and will not be deployed for real-time clinical decision-making in this study.
详细描述
This is a single-center, retrospective, non-interventional methodological cohort study using routinely collected structured data from the ICCA reporting-layer database at Zhongshan Hospital, Fudan University. The source population comprises adult ICU patients admitted between September 2021 and May 31, 2026 who have an extractable and uniquely identifiable ICU encounter. No intervention will be assigned, no clinical decision will be altered, and no additional examination, treatment, follow-up visit, or biospecimen collection will be performed.
The unit of participant-level registration is the patient, while the principal analytic structure is the ICU encounter and the patient-day. ICU admission time will serve as the common temporal anchor. Monitoring, laboratory, fluid, medication, organ-support, diagnostic, and demographic data will be extracted from the ICCA reporting layer and aggregated primarily into consecutive 24-hour windows. Alternative 12-hour or shorter windows may be evaluated in sensitivity analyses.
Daily physiological state vectors will be constructed across 10 domains: oxygenation; ventilation and respiratory drive; hemodynamic perfusion; renal-fluid balance; hepatic-metabolic clearance; inflammation-immune activation; coagulation-blood integrity; brain-autonomic regulation; bioenergetic and acid-base status; and treatment-support burden. Prespecified data-governance rules will be used for variable-source mapping, unit harmonization, time alignment, limited carry-forward, missing-data handling, and physiological-range checks.
Principal component analysis will provide the primary low-dimensional state-space representation. UMAP may be used for supplementary visualization and local-structure exploration but will not be the sole primary analytical framework. Enhanced trajectory features will include state position, displacement, trajectory length, speed, acceleration, turning angle, curvature, local variability, lag-1 autocorrelation, recovery slope, and cross-domain coupling. These features will be used to characterize high-risk regions, possible basin crossings and critical transitions, and physiological resilience.
Eligible records will be divided chronologically into an earlier derivation cohort and a later temporal validation cohort, with an intended split of approximately 70% and 30%, respectively. The exact cutoff will be locked before analysis. The primary analysis will evaluate the association between state-space and trajectory features and a composite clinical deterioration outcome occurring within 72 hours after each eligible index patient-day. Multivariable logistic regression or discrete-time risk models will be used for the primary outcome. ICU and in-hospital mortality may be evaluated using Cox regression or competing-risk methods, and other outcomes will be analyzed with appropriate regression or time-to-event models. Internal validation will use the temporal validation cohort and bootstrap resampling to assess discrimination, calibration, and robustness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Admission to an ICU at Zhongshan Hospital, Fudan University between September 2021 and May 31, 2026, with a uniquely identifiable ICU encounter in the ICCA reporting-layer database.
- •ICU length of stay of at least 24 hours.
- •Availability of core variables from at least four physiological domains and at least one patient-day suitable for modeling.
排除标准
- •Duplicate import of the same ICU encounter that cannot be reliably deduplicated.
- •Severe missingness, inconsistency, or irreconcilable error in key identifiers, ICU admission/discharge times, or core timestamps.
- •Test data, demonstration data, or records determined through data governance to be non-genuine patient records.
- •Inability to lock the primary source mapping for key variables, or overall data quality insufficient to support construction of the physiological state vector.
结局指标
主要结局
Composite Clinical Deterioration Within 72 Hours
时间窗: Within 72 hours following each eligible index patient-day
A binary composite outcome defined by the occurrence of at least one of the following events during the 72-hour window after an eligible index patient-day: ICU death; new initiation of invasive mechanical ventilation; new initiation of continuous renal replacement therapy (CRRT); new initiation of extracorporeal membrane oxygenation (ECMO); or a prespecified significant escalation in vasoactive medication support. A participant/index window meeting more than one component will be counted once for the composite outcome.
次要结局
- ICU mortality(From ICU admission through ICU discharge, an average of approximately 5 days)
- In-Hospital Mortality(From hospital admission through hospital discharge, an average of approximately 30 days)
- Duration of Invasive Mechanical Ventilation(From ICU admission through ICU discharge, an average of approximately 5 days)
- Duration of Continuous Renal Replacement Therapy(From ICU admission through ICU discharge, an average of approximately 5 days)
- Duration of Vasoactive Medication Exposure(From ICU admission through ICU discharge, an average of approximately 5 days)
- ICU Length of Stay(From ICU admission through ICU discharge, an average of approximately 5 days)
- Hospital Length of Stay(From hospital admission through hospital discharge, an average of approximately 30 days)
研究者
Ming Zhong
Director, Department of Critical Care Medicine
Shanghai Zhongshan Hospital