Overview
Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage
Status:
Completed
Completed
Trial end date:
2020-09-23
2020-09-23
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and improving the prognosis of patients.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Xijing HospitalTreatments:
Glyburide
Imidacloprid
Criteria
Inclusion Criteria:1. Age 18-70 years with a primary ICH
2. A baseline CT with basal ganglia hemorrhage of 5 to 30 mL
3. Glasgow Coma Scale (GCS) score ≥ 6
4. Symptom onset less than 72 hours prior to admission
5. Informed consent
Exclusion Criteria:
1. Supratentorial ICH planned to evacuation of a large hematoma
2. Hemorrhage breaking into ventricles of brain
3. Prior significant disability (mRS ≥ 3)
4. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR
<30ml/min/1.73m2
5. Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
6. Blood glucose < 55 mg/dL (3.1 mmol/L)at enrollment, or with the history of
hypoglycemia
7. With acute ST elevation infarction, or decompensated heart failure, or cardiac arrest,
or acute coronary syndrome, or known history of admission for acute coronary syndrome,
or acute myocardial infarction, or coronary intervention in the past 3 months
8. Treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus
metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and
glibornuride
9. Treatment with bosentan in the past 7 days
10. Be allergic to sulfa or other sulfonylurea drugs
11. Known G6PD deficiency
12. Pregnant women
13. Breast-feeding women disagreeing to participate the study or stop breastfeeding during
and after the study
14. Be enrolled in other non-observation-only study with receiving an investigational drug
15. Refusing to be enrolled, or having poor compliance, or tending to withdraw