StrokePhase 2NCT05375240
Propranolol on Post Stroke Immune Status and Infection
A Phase 2 study testing Propranolol and Ceftriaxone in people with Stroke and Cerebrovascular Disorders, run by Tianjin Medical University General Hospital at 2 sites in China.
Trial summary
Stroke-associated pneumonia (SAP) is one of the important risk factors influencing poor outcomes and death in stroke patients. Over the past two decades, accumulating evidence suggests that post-stroke brain injury mobilizes the adrenergic system, which induces post-stroke immunosuppression and SAP. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Ischemic Stroke
- What is being tested?
- Propranolol and Ceftriaxone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2022to Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 60 years older and less than 90 years.
- Onset of new neurological deficits within 24 hours at the time of randomization and propranolol treatment can be initiated within 24 hours of symptom onset.
- Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
- 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.
- MRI or CT scan confirmed stroke.
- Inability to tolerate normal diet or fluids because of: a. impaired consciousness levels; b. failed clinical bedside swallowing assessment performed by a trained and qualified assessor; c. "nil orally" orders, nasogastric tubes, modified diet or requiring compensatory feeding techniques.
- TOAST: Large-artery atherosclerosis.
- Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
Who cannot join
- Time of symptom onset that cannot be reliably assessed.
- Subjects considered as candidates for immediate surgical intervention by the neurosurgery service.
- Pregnancy or parturition within previous 30 days or active lactation.
- Coagulation disorders (platelet count less than 50x109/L, elevated baseline APTT or INR>1.3) or use of anti-coagulant drugs within the last 24 hours.
- Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol) or antibiotics within 30 days.
- Use of reserpine within the last 30 days.
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- Pre-stroke dementia or disability.
- Admission with any of following signs: 1). Fever>38℃; 2). Signs of pneumonia in chest CT scan; 3). White blood cell count>12000 or <4000 /μL; 4). Cough, sputum or dyspnea; 5). Respiratory rate>25.
- Severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
- Bronchial asthma or COPD.
- Cardiogenic shock.
- Severe or acute heart failure.
- Degree II-III atrioventricular block.
- Sinus bradycardia (heart rate ≤75/min).
- Known anergic to propranolol or amoxicillin.
- Current participation in other interventional clinical trials.
- Immunosuppressant therapy or known immunosuppression.
- Inability to undergo neuroimaging with magnetic resonance.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital
Beijing, 100070
Fu-Dong Shi, MD,PhD
Tianjin Medical University General Hospital
Tianjin, 300052
Fu-Dong Shi, MD,PhD
About this study
Official title: A Randomized, Blank-controlled, Open Label Study of the Safety and Efficacy of Propranolol in Reducing Stroke Associated Pneumonia and Urinary Tract Infection
Stroke-associated pneumonia (SAP) is one of the important risk factors influencing poor outcomes and death in stroke patients. Over the past two decades, accumulating evidence suggests that post-stroke brain injury mobilizes the adrenergic system, which induces post-stroke immunosuppression and SAP. This study is designed to test the safety and efficacy of an adrenergic β-receptor blocker, propranolol, with or without combination of antibiotics, in reducing SAP in stroke patients. The underlying immune mechanisms will be investigated.
Read the detailed description
Stroke patients meeting the inclusion criteria will be randomly assigned at a 1:1:1 ratio into groups of standard treatment (blank-controlled), propranolol, or propranolol + ceftriaxone.
Patients will be given 10.0mg*3/day oral/nil propranolol alone or combined with 2.0g/day intravenous ceftriaxone over the course of 7 consecutive days. Neurological functions of these patients will be assessed at the baseline, day 7, 14, 30, and 90 after randomization. Head magnetic resonance imaging (MRI) will be performed at baseline and 7 days after randomization. Chest computed tomography (CT) will be performed within 7 days following randomization. Abdomen CT will be performed simultaneously with CT chest to evaluate spleen volume. For patients requiring acute endotracheal intubation upon admission, bronchoalveolar lavage fluid will be harvested at baseline and 7 days post-randomization. For all patients, 15 mL intravenous blood will be collected at baseline, days 3 and 7 after randomization. Bronchoalveolar lavage fluid and blood will be used to explore the peripheral and pulmonary immune status of patients. Urinary tract infection will be evaluated within 14 days based on routine urine test and bacterial culture.
- Conditions
- Stroke, Cerebrovascular Disorders, Ischemic Stroke, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Being tested
- Propranolol, Ceftriaxone
- Keywords
- Stroke, Propranolol, Infection, Treatment
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Ischemic Stroke, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Propranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset.
CeftriaxoneDrug
Intravenously 2.0g/day for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Blank-control group | No intervention | Patients will receive standard treatment. |
| Oropranolol group | Experimental | Propranolol will be administered at a dose of 10mg*3/day over a course of 7 consecutive days after stroke onset. Receives: Drug: Propranolol |
| Propranolol + ceftriaxone group | Experimental | Propranolol will be administered at a dose of 10mg*3/day combined with 2g/day ceftriaxone over a course of 7 consecutive days after stroke onset. Receives: Drug: Propranolol; Drug: Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
Measured: Up to 7 days
Secondary outcomes (10)
Assessment of clinical outcome by National Institute of Healthy Stroke Scale
National Institute of Healthy Stroke Scale(0-42 score),higher scores mean a worse outcome.
Measured: Up to 90 days
Assessment of clinical outcome by modified Barthel Index
Modified Barthel Index（0-100 score),higher scores mean a better outcome.
Measured: Up to 90 days
Assessment of clinical outcome by modified Rankin Scale
Modified Rankin Scale(0-5 score),higher scores mean a worse outcome.
Measured: Up to 90 days
Assessment of clinical outcome by Glasgow Coma Scale
Glasgow Coma Scale(0-15),higher scores mean a better outcome.
Measured: Up to 90 days
Incidence of urinary tract infection
Urinary tract infection diagnosed with defined criteria.
Measured: Up to 14 days
Incidence of sepsis
Sepsis diagnosed with defined criteria.
Measured: Up to 14 days
Alterations of spleen volume
Spleen volume will be evaluated within 7 days via abdomen CT scan.
Measured: Up to 7 days
Single cell sequencing results of immune cells from blood and bronchoalveolar lavage fluid
Single cell sequencing of immune cells from blood and bronchoalveolar lavage fluid will be conducted at baseline and 7 days after stroke onset.
Measured: Up to 7 days
Concentration of soluble protein in blood and bronchoalveolar lavage fluid
Soluble proteins in blood and bronchoalveolar lavage fluid will be evaluated by O-link at baseline and 7 days after stroke onset
Measured: Up to 7 days
Counts of lymphocytes in blood
Counts of lymphocytes will be evaluated by flow cytometry at baseline, day 3, and day 7 post stroke onset
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu-Dong Shi, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375240
- Sponsor's protocol ID
- IRB2022-YX-001
- Status last verified
- May 2022
- First submitted
- 19 Apr 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blank-controlled, Open Label Study of the Safety and Efficacy of Propranolol in Reducing Stroke Associated Pneumonia and Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05375240
- Acronym / sponsor ID
- IRB2022-YX-001
- Conditions
- Stroke, Cerebrovascular Disorders, Ischemic Stroke, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Keywords
- Stroke, Propranolol, Infection, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke-associated pneumonia (SAP) is one of the important risk factors influencing poor outcomes and death in stroke patients. Over the past two decades, accumulating evidence suggests that post-stroke brain injury mobilizes the adrenergic system, which induces post-stroke immunosuppression and SAP. This study is designed to test the safety and efficacy of an adrenergic β-receptor blocker, propranolol, with or without combination of antibiotics, in reducing SAP in stroke patients. The underlying immune mechanisms will be investigated.
Detailed description
Stroke patients meeting the inclusion criteria will be randomly assigned at a 1:1:1 ratio into groups of standard treatment (blank-controlled), propranolol, or propranolol + ceftriaxone.
Patients will be given 10.0mg*3/day oral/nil propranolol alone or combined with 2.0g/day intravenous ceftriaxone over the course of 7 consecutive days. Neurological functions of these patients will be assessed at the baseline, day 7, 14, 30, and 90 after randomization. Head magnetic resonance imaging (MRI) will be performed at baseline and 7 days after randomization. Chest computed tomography (CT) will be performed within 7 days following randomization. Abdomen CT will be performed simultaneously with CT chest to evaluate spleen volume. For patients requiring acute endotracheal intubation upon admission, bronchoalveolar lavage fluid will be harvested at baseline and 7 days post-randomization. For all patients, 15 mL intravenous blood will be collected at baseline, days 3 and 7 after randomization. Bronchoalveolar lavage fluid and blood will be used to explore the peripheral and pulmonary immune status of patients. Urinary tract infection will be evaluated within 14 days based on routine urine test and bacterial culture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blank-control group | No intervention | –Patients will receive standard treatment. |
| Oropranolol group | Experimental | Drug: PropranololPropranolol will be administered at a dose of 10mg*3/day over a course of 7 consecutive days after stroke onset. |
| Propranolol + ceftriaxone group | Experimental | Drug: Propranolol, Drug: CeftriaxonePropranolol will be administered at a dose of 10mg*3/day combined with 2g/day ceftriaxone over a course of 7 consecutive days after stroke onset. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 60 years older and less than 90 years.
- Onset of new neurological deficits within 24 hours at the time of randomization and propranolol treatment can be initiated within 24 hours of symptom onset.
- Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
- 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.
- MRI or CT scan confirmed stroke.
Key exclusion criteria (18 listed)
- Time of symptom onset that cannot be reliably assessed.
- Subjects considered as candidates for immediate surgical intervention by the neurosurgery service.
- Pregnancy or parturition within previous 30 days or active lactation.
- Coagulation disorders (platelet count less than 50x109/L, elevated baseline APTT or INR>1.3) or use of anti-coagulant drugs within the last 24 hours.
- Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol) or antibiotics within 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololPropranolol will be given at a dose of 10 mg orally, 3 times per day, for 7 consecutive days after stroke onset. | Drug | Oropranolol group, Propranolol + ceftriaxone group |
| CeftriaxoneIntravenously 2.0g/day for 7 consecutive days. | Drug | Propranolol + ceftriaxone group |
Primary outcome
Incidence of pneumonia
Time frame: Up to 7 days
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
10 secondary outcomes
Assessment of clinical outcome by National Institute of Healthy Stroke Scale
Time frame: Up to 90 days
Assessment of clinical outcome by modified Barthel Index
Time frame: Up to 90 days
Assessment of clinical outcome by modified Rankin Scale
Time frame: Up to 90 days
Assessment of clinical outcome by Glasgow Coma Scale
Time frame: Up to 90 days
Incidence of urinary tract infection
Time frame: Up to 14 days
Incidence of sepsis
Time frame: Up to 14 days
Alterations of spleen volume
Time frame: Up to 7 days
Single cell sequencing results of immune cells from blood and bronchoalveolar lavage fluid
Time frame: Up to 7 days
Concentration of soluble protein in blood and bronchoalveolar lavage fluid
Time frame: Up to 7 days
Counts of lymphocytes in blood
Time frame: Up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol and Ceftriaxone in people with Stroke and Cerebrovascular Disorders, run by Tianjin Medical University General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu-Dong Shi, Ph.D (+8615822011530, fshi@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonia (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.