Effect of landilolol use on patient outcomes after acute brain injury surgery: a multicenter, prospective, open-label randomized controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400092859

Enrollment

Unknown

Registered

2024-11-25

Start date

2024-12-01

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute brain injury

Interventions

Landiolol treatment group:Using Landiolol

Non-landiolol treatment group:Not using landiolol

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age>=18 years; (2) Severe acute brain injury, including traumatic and non-traumatic brain injury, GCS score has been 96 hours

Exclusion criteria

Exclusion criteria: (1) Brain-dead patients; (2) Untreated patients with severe hemodynamic instability (active uncontrolled bleeding, norepinephrine >=0.5 µg/kg/min or use of two or more vasoactive drugs to maintain blood pressure and cardiac output, etc.); (3) cardiogenic shock, acute congestive heart failure, or previous chronic heart failure (NYHA grade 3-4); (4) sinus bradycardia, sick sinus syndrome or atrioventricular nodal conduction disorder (including second-degree or third-degree heart block); (5) the presence of pacemaker, aortic balloon counterpulsation, or cardiopulmonary bypass support; (6) Patients with untreated pheochromocytoma or paraganglioma; (7) severe pulmonary hypertension (mean pulmonary artery pressure> 55mmHg); (8) Patients with diabetic ketoacidosis; (9) Pregnant or lactating patients; (10) Advanced malignant tumor; (11) Allergy to landilolol components or have used drugs that are compatible with landilol; (12) Ongoing use of other ß blockers and other anti-arrhythmic drugs; (13) Patients who have been enrolled in other clinical trials

Design outcomes

Primary

Measure	Time frame
In Hospital Mortality;	—

Secondary

Measure	Time frame
GCS, Glasgow Coma Scale;ICP values during the intervention period;Time for ICP to decrease to normal (hours);Highest PSH score within 2 weeks of enrollment;Normetanephrine;Metanephrine;Cardiac Troponin I;N-terminal pro-B-type natriuretic peptide;Incidence and frequency of new-onset arrhythmias;Rate of improvement in systolic function at echocardiography;Rate of improvement in diastolic function on echocardiography;Time without mechanical ventilation within 28 days (days);6-month mortality;Days of hospitalization in ICU;Total days of hospitalization;The Glasgow Outcome Score was extended at six months;Quality of life at 6 months;Incidence of severe hypotension (systolic blood pressure <90 mmHg);Incidence of severe bradycardia (heart rate <30 beats/minute);Incidence of second or third degree AV block;	—

Measure

Time frame

GCS, Glasgow Coma Scale;ICP values during the intervention period;Time for ICP to decrease to normal (hours);Highest PSH score within 2 weeks of enrollment;Normetanephrine;Metanephrine;Cardiac Troponin I;N-terminal pro-B-type natriuretic peptide;Incidence and frequency of new-onset arrhythmias;Rate of improvement in systolic function at echocardiography;Rate of improvement in diastolic function on echocardiography;Time without mechanical ventilation within 28 days (days);6-month mortality;Days of hospitalization in ICU;Total days of hospitalization;The Glasgow Outcome Score was extended at six months;Quality of life at 6 months;Incidence of severe hypotension (systolic blood pressure <90 mmHg);Incidence of severe bradycardia (heart rate <30 beats/minute);Incidence of second or third degree AV block;

—

Countries

China

Contacts

Public ContactXiuling Shang

Department of Critical Care Medicine, Fujian Provincial Hospital

zksxling@163.com+86 137 6389 5158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026