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NCT07846995

Predicting Early Circulatory Deterioration After Short-Acting Beta-Blocker Treatment in Intensive Care Patients

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

This retrospective observational study used existing intensive care records to examine whether heart rate and blood pressure measured before short-acting beta-blocker treatment could help predict early signs of worsening circulation recorded after treatment. The study included patients who had received intravenous esmolol or landiolol during routine care. Researchers did not assign treatment or change patient care. The main analysis used records from Zhongshan Hospital, Fudan University. Additional intensive care databases were used to evaluate whether a prediction model developed at this hospital could be applied to other patient populations. The main questions were whether pretreatment heart rate and blood pressure could predict recorded circulatory changes, whether combining these measurements improved prediction over simpler blood pressure measures, and whether differences in blood pressure monitoring affected the findings. The main outcome combined a recorded fall in blood pressure, initiation or escalation of norepinephrine (a medicine used to support blood pressure), or early discontinuation of the same beta-blocker. Blood pressure and norepinephrine changes were assessed during the first three hours after the treatment index, and drug discontinuation during the first hour. External database analyses focused on recorded low blood pressure during the first three hours. The study evaluated prediction among patients who had already received treatment. It was not designed to determine whether beta-blockers caused these events or whether a patient should receive a beta-blocker. Data collection and the analyses described here were completed before registration.

Official title: Pretreatment Haemodynamic Prediction of Recorded Early Circulatory Deterioration After Documented Short-Acting Beta-Blocker Treatment in Intensive Care: A Retrospective Multicohort Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

2541

Start Date

2026-08-01

Completion Date

2026-09-22

Last Updated

2026-09-29

Healthy Volunteers

Not specified

Conditions

Critical Illness

Interventions

DRUG

Esmolol

Intravenous esmolol administered during routine intensive care, as documented in existing medication records. Treatment selection, dose, and duration were determined by treating clinicians. Esmolol exposure was identified retrospectively; no treatment was assigned or modified by the study.

DRUG

Landiolol

Intravenous landiolol administered during routine intensive care, as documented in existing medication records. Treatment selection, dose, and duration were determined by treating clinicians. Landiolol exposure was identified retrospectively; no treatment was assigned or modified by the study.

Inclusion Criteria: * ICU patients with routinely collected medication and physiological records in ICCA at Zhongshan Hospital, Fudan University, or in MIMIC-IV, eICU, AmsterdamUMCdb, HiRID, or SICdb. * Documented intravenous esmolol or landiolol treatment in ICCA, or documented intravenous esmolol treatment in the external validation cohorts. * An identifiable treatment index according to database-specific medication-record rules. ICCA required a timestamp-verified treatment start. In eICU, the index was the first documented positive-rate infusion record rather than a verified initiation time. * The last recorded mean arterial pressure within 30 minutes before the treatment index was at least 65 mmHg. * At least one mean arterial pressure measurement was recorded after the treatment index and within 180 minutes. * Documented ICU presence extended through 180 minutes after the treatment index. * Pretreatment heart rate, diastolic blood pressure, and pulse pressure were available to calculate the model predictors within the 120 minutes before the treatment index. Exclusion Criteria: * Medication records that could not be mapped unambiguously to the patient, ICU stay, study drug, or treatment index. * In ICCA, candidate starts with a conflicting same-time stop or an unresolved continuation or restart. * No qualifying baseline mean arterial pressure measurement, or a last baseline mean arterial pressure below 65 mmHg. * No mean arterial pressure measurement in the 180-minute post-index window. * Insufficient documented ICU presence through 180 minutes after the treatment index. * Missing pretreatment measurements required to calculate the model predictors. Record-selection rules: * The first accepted treatment index per patient was selected before assessing outcome completeness in each cohort; later courses were not substituted when this first index failed eligibility requirements. * Duplicate medication records at the same patient, stay, drug, and timestamp were collapsed. * Physiological measurements recorded exactly at the treatment index were excluded because their temporal order relative to drug administration was uncertain.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China