Assessment of safety and effectiveness of continuous intravenous labetalol infusion for blood pressure control in patients with spontaneous intracerebral hemorrhage: a STROBE-compliant observational study

Background Current evidence on continuous labetalol infusion for blood pressure (BP) control in spontaneous intracerebral hemorrhage (SICH) is limited with unclear information on higher doses. Objectives To evaluate the effectiveness and safety of continuous labetalol in SICH patients. Methods We conducted a prospective, single-arm observational study involving SICH patients who received continuous labetalol infusion to achieve and maintain target BP (<140/90 mmHg). Effective outcomes included BP control, the time required to achieve the target BP, BP variability, and hematoma expansion. Safety outcomes included adverse event (AE) rates and predictive factors. Subgroup analyses were performed by categorizing patients into low (≤300 mg) and high (>300 mg) cumulative dose groups within 24 hours. Results A total of 84 patients were available for analysis. The median time to reach target BP was 2.0 hours (interquartile range, IQR: 0.5 – 3.3 hours), and the median percentage of time at target BP was 53% (IQR: 35 – 66%). The BP profile suggested stable BP control over 24 hours. Hematoma expansion was observed in 8.3% of patients. During continuous labetalol infusion, 42 AEs were reported in 19 patients, with bradycardia being the most common (22.6%). However, no resuscitation was required. The incidence of bradycardia or hypotension appeared to be comparable between the low and high cumulative dose groups. Predictive factors for AEs included baseline systolic BP (SBP), baseline heart rate (HR), and diabetes, all having an inverse relationship with the probability of AEs. Conclusion Continuous labetalol infusion provides effective and sustained BP control in SICH, with an acceptable safety profile at cumulative doses exceeding 300 mg. Lower baseline SBP and HR were associated with a higher risk of AEs and may help identify patients requiring closer monitoring. The study was registered with the Thai Clinical Trials Registry (TCTR20240423003) and can be accessed at https://www.thaiclinicaltrials.org/show/TCTR20240423003 .