Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
Project Name:
Randomized Controlled Clinical Study on oral hygiene and prophylactic antibiotics to prevent Intracerebral Hemorrhage associated pneumonia
Research Objectives:
To evaluate the effectiveness, safety and health economics value of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
1. To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 2. To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 3. To clarify the health economics value of low-intensity enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
Research Design:
Research Type: Multicenter, Randomized, Controlled, Open Label, Blinded Endpoint Research Design Research Hypothesis: Intensive oral hygiene combined with antibiotic treatment is beneficial in reducing the incidence of pulmonary infections related to cerebral hemorrhage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years old;
Spontaneous intracerebral hemorrhage;
Supratentorial intracerebral hemorrhage (ICH);
Hematoma volume < 30 ml (calculated by ABC/2 method);
Disqualifiers
Secondary intracerebral hemorrhage, such as that resulting from cerebral aneurysms, cerebral arteriovenous malformations, brain tumors, cerebral venous system thrombosis, antithrombotic therapy (antiplatelet, anticoagulant therapy, etc.), hemorrhagic transformation after cerebral infarction, hematological diseases, etc.
The patient's clinical symptoms and signs suggest signs of brain herniation, such as progressive decline in consciousness level, weakened or absent pupillary light reflex.
Obvious signs of pneumonia already exist, such as fever, persistent cough or yellow purulent sputum, and imaging examinations (chest X-ray or chest CT) suggest signs of pneumonia; two consecutive measurements of body temperature ≥ 37.5℃, or one measurement of body temperature ≥ 38.0℃.
A history of severe cardiovascular disease, meeting any of the following: 1) Heart failure (New York Heart Association functional class ≥ III); 2) Unstable angina within 3 months; 3) Any supraventricular or ventricular arrhythmia requiring treatment; 4) Prolonged QTc interval considered clinically significant by the investigator (reference range: > 450ms for men, > 470ms for women) (Note: QTc interval must be calculated according to Fridericia's formula); 5) Complete atrioventricular block and left or right bundle branch block requiring treatment; 6) Acute myocardial infarction or interventional treatment within 1 month; high-risk patients with chronic arrhythmia, such as sick sinus syndrome, second or third-degree atrioventricular block, bradycardia-related syncope without pacemaker installation, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
wether apply enhanced oral care combined with prophylactic antibiotics
Biological/VaccineIntervention group: After randomization, immediate intensive oral hygiene treatment (chlorhexidine 20 ml, three times a day) combined with antibiotics (ceftazidime 1 g, every 8 hours) was administered on the basis of the conventional standard treatment, and the treatment lasted for 3 days; Control group: Conventional standard treatment combined with routine oral care (normal saline 20 ml, twice a day), and detailed records were made of the specific measures of patient oral care, including the selection of cleaning solution and frequency.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: enhanced oral care combined with prophylactic antibioticsActive comparator 1 intervention
Group B: conventional standard treatment combined with conventional oral careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The occurrence of pneumonia related to cerebral hemorrhage
The occurrence of pneumonia related to cerebral hemorrhage
Time frame
From enrollment to the 10th day after randomization or at the time of dischargeSecondary outcomes
1
urinary tract infection or other systemic infection
urinary tract infection or other systemic infection
Time frame
From enrollment to the 10th day after randomization or at discharge2
Improvement in neurological dysfunction (NIHSS10d-NIHSS group)
This study used the difference between the NIH Stroke Scale (NIHSS, 0-42) score on the 10th day after randomization or at discharge and the NIHSS score (0-42) at the time of enrollment to represent the change in neurological dysfunction (NIHSS10d-NIHSS group). The smaller the difference, or even a negative value, the better the improvement in neurological dysfunction. Conversely, the larger the difference, the worse the improvement.
Time frame
From enrollment to the 10th day after randomization or at discharge3
Length of hospital stay
The period from the patient's admission to the patient's discharge.It is the date of discharge minus the date of admission
Time frame
From hospital admission until discharge (anticipated average 7-10 days)4
direct medical expenses during hospitalization
The direct expenses incurred by the patient during the hospitalization period.
Time frame
From hospital admission until discharge (anticipated average 7-10 days)Sponsors and contacts
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Source ClinicalTrials.gov