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A randomized controlled clinical study on strengthening oral care combined with antibiotics for the prevention of cerebral hemorrhage related pneumonia

A randomized controlled clinical study on strengthening oral care combined with antibiotics for the prevention of cerebral hemorrhage related pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114362
Enrollment
Unknown
Registered
2025-12-10
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Cerebral hemorrhage

Interventions

Intervention group:After randomization, in addition to routine standard care, enhanced oral care (chlorhexidine 20ml Qid) combined with antibiotics (ceftazidime 1g Q8h) was administered immediately fo
Control group:Routine standard care combined with routine oral care (normal saline 20 ml BID)

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18-80 years old; 2. Spontaneous cerebral parenchymal hemorrhage; 3. Supertentorial intracerebral hemorrhage (ICH); 4. Hematoma volume is less than 30ml (calculated by ABC/2 method); 5. Glasgow Coma Scale >= 9 points at random; 6. The time from onset to randomization is = 8 points; 8. Informed consent from patients and/or their families.

Exclusion criteria

Exclusion criteria: 1. Secondary cerebral hemorrhage, such as secondary to cerebral aneurysms, cerebral arteriovenous malformations, brain tumors, cerebral venous thrombosis, antithrombotic therapy (antiplatelet, anticoagulant therapy, etc.), hemorrhagic transformation after cerebral infarction, hematological diseases, etc. 2. Clinical symptoms and signs of the patient indicate signs of cerebral herniation, such as progressive decrease in consciousness level, weakened or absent pupil reflex to light; 3. There are already obvious signs of pneumonia, such as fever, persistent cough or cough with yellow purulent sputum, and imaging examinations (chest X-rays or chest CT) indicating signs of pneumonia; Two consecutive measurements of body temperature >= 37.5 °C, or one measurement of body temperature >= 38.0 °C; 4. A history of severe cardiovascular disease, meeting any of the following criteria: 1) heart failure (New York Heart Association functional class >= III); 2) Unstable angina pectoris within 3 months; 3) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment; 4) Researchers believe that clinically significant QTc interval prolongation (reference range for males>450ms, females>470ms) (note: QTc interval must be calculated according to Fridericia's criteria); 5) Complete atrioventricular block and left and right bundle branch block requiring treatment; 6) Acute myocardial infarction or interventional treatment within the past month; High risk of chronic arrhythmia, such as sinus syndrome, second or third degree atrioventricular block, bradycardia related syncope without pacemaker, etc; 5. Diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST>3 times the upper limit of normal values; 6. Severe renal insufficiency: such as patients undergoing dialysis, or diagnosed with severe active kidney disease, or creatinine clearance rate<50mL/min; 7. Patients with other serious illnesses whose life expectancy is less than one year; 8. Patients who plan to undergo surgical intervention treatment before the first administration, including but not limited to hematoma evacuation surgery (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and ventricular puncture external drainage; 9. Unable to understand the research procedure and/or complete follow-up due to factors such as mental illness, cognitive impairment, emotional disorders, etc. 10. Pregnant or lactating women; 11. Participated in other clinical studies within 3 months or is currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Occurrence of pneumonia ;

Secondary

MeasureTime frame
Urinary tract infection or infections of other systems;NIHSS10d-NIHSS basline ;Length of Stay;direct medical costs;short-term prognosis;

Countries

China

Contacts

Public ContactGuo junping

Beijing Tiantan Hospital, Capital Medical University

guojunpingttyy@163.com+86 136 2109 1361

Outcome results

None listed

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