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Completed

NCT Number: NCT07627607

Early Prediction of ICU Hypotension Using Machine Learning

This prospective observational study aims to develop and internally validate a machine learning model for the early prediction of hypotension in adult intensive care unit patients. The model will use routinely collected non-invasive vital signs, heart rate, medication-dose records, and fluid-balance data recorded during standard ICU care. No intervention will be assigned by the study, and patient management will not be changed according to the model output. The primary aim is to predict hypotension 30 minutes before its occurrence; shorter 5- and 15-minute prediction horizons will also be evaluated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kutahya City Hospital

Kütahya, 43100, Turkey (Türkiye)

About this study

Hypotension is a frequent hemodynamic event in critically ill patients and may occur before clear clinical deterioration is recognized. Earlier identification of patients at risk may support closer clinical attention and more timely evaluation. This study is designed as a prospective, observational machine learning study in adult intensive care unit patients.

Routinely available ICU data will be collected at five-minute intervals, including systolic, mean, and diastolic non-invasive blood pressure, heart rate, medication-dose entries, and fluid-balance records. These data will be used to construct time-dependent features reflecting recent values, short-term changes, and rolling trends. Hypotension will be defined at each five-minute time point as systolic blood pressure below 90 mmHg, mean arterial pressure below 65 mmHg, or diastolic blood pressure below 60 mmHg.

The primary prediction horizon will be 30 minutes. Separate secondary analyses will evaluate 5- and 15-minute prediction horizons. A gradient-boosted decision-tree model will be developed and internally validated using patient-level data partitioning to avoid assigning observations from the same patient to both training and validation sets. Model performance will be assessed using discrimination, classification performance, and calibration measures. Feature-importance analyses will be used to describe the variables contributing to model predictions.

The study is observational. No treatment, medication, device, alarm, or clinical decision will be assigned by the study protocol. The prediction model will be developed and evaluated using collected data and will not be used to guide real-time patient management during the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Admission to the adult intensive care unit during the study period
  • Length of stay in the intensive care unit of at least 24 hours
  • Availability of routine intensive care unit monitoring data
  • Availability of non-invasive blood pressure and heart rate measurements recorded during ICU monitoring
  • Availability of medication-dose and/or fluid-balance records during ICU monitoring

Exclusion criteria

  • Age younger than 18 years
  • Length of stay in the intensive care unit of less than 24 hours
  • Absence of usable blood pressure monitoring data
  • Records with irrecoverable timestamp inconsistencies
  • Insufficient monitoring duration for feature construction and future outcome labeling

Treatment and study plan

Routine ICU Data Collection

Other

Routinely collected intensive care unit data, including non-invasive blood pressure, heart rate, medication-dose records, and fluid-balance data, will be recorded and analyzed for development and internal validation of a machine learning model. The study does not assign any treatment, medication, device, alarm, or clinical decision.

Primary outcomes

  1. Area Under the Receiver Operating Characteristic Curve for 30-Minute Hypotension Prediction

    Time frame: From enrollment through the end of ICU monitoring, up to 4 months

    Discriminative performance of the machine learning model for predicting hypotension 30 minutes before its occurrence. Hypotension will be defined as systolic blood pressure below 90 mmHg, mean arterial pressure below 65 mmHg, or diastolic blood pressure below 60 mmHg at a five-minute observation point.

Secondary outcomes

  1. Area Under the Receiver Operating Characteristic Curve for 5- and 15-Minute Hypotension Prediction

    Time frame: From enrollment through the end of ICU monitoring, up to 4 months

    Discriminative performance of separate machine learning models for predicting hypotension at 5-minute and 15-minute prediction horizons.

  2. Classification Performance of the Hypotension Prediction Model

    Time frame: From enrollment through the end of ICU monitoring, up to 4 months

    Classification performance of the machine learning model will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, and F1 score at predefined classification thresholds.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

A Prospective Observational Machine Learning Study for the Early Prediction of Hypotension in Adult Intensive Care Unit Patients

Acronym: ICU-HypoAI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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