PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)

• Status: Not yet recruiting
• Trial end date: 2025-07-03
• Target enrollment: 0
• Participant gender: All

Summary

Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumonia and other infections limit the overall efficacy of stroke management. Increasing evidence suggests that sympathetic nervous system activity contributes to post stroke immunosuppression and emergence of infections. This study is designed to test the safety and efficacy of an adrenergic β receptor blocker propranolol in reducing SAP in hemorrhagic stroke patients, in multi-center, randomized, placebo controlled, double blinded fashion.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Ceftriaxone; Propranolol

Criteria

Inclusion Criteria:

1. Age 60 years older and no more than 90 years.

2. Onset of new neurological deficits within≤24 hours at the time of randomization

3. CT scan demonstrates parenchymal hemorrhage.

4. Initial NIHSS score of 11 or greater or Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater and no more than 12 at time of enrollment.

5. Unable to tolerate normal diet or fluids because of:

1. impaired consciousness levels.

2. failed clinical bedside swallowing assessment performed by a trained assessor.

3. "nil orally" orders, nasogastric tubes, modified diet or requiring compensatory feeding techniques.

6. Admission without infection signs. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.

Exclusion Criteria:

1. Time of symptom onset cannot be reliably assessed.

2. Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service.

3. Pregnancy or parturition within previous 30 days or active lactation.

4. Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, and etc.) or antibiotics within the last 30 days.

5. Use of reserpine within the last 30 days.

6. Pre-stroke dementia or disability.

7. With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.

8. Bronchial asthma or COPD.

9. Cardiogenic shock or severe or acute heart failure.

10. Degree II-III atrioventricular block or sinus bradycardia (heart rate ≤75/min).

11. Known sensitivity to propranolol.

12. Currently participating in other interventional clinical trials.

13. Immunosuppressant therapy or known immunosuppression.