Hypertensive emergencies and hypertensive subemergency that require rapid control of blood pressure with intravenous medication
Conditions
Interventions
Experimental group:Use a microinjection pump to infuse the experimental clevidipine butyrate emulsion for injection intravenously, and select peripheral vein or central vein.
Control group:The positive control drug clevidipine butyrate emulsion for injection was intravenously infused with a microinjection pump, and peripheral vein or central vein was selected.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = 180 mmHg and/or office diastolic blood pressure (DBP) >= 120 mmHg, with or without target organ damage, two consecutive blood pressure measurements, at least 15 minutes apart, both blood pressure values ??require SBP >= 180 mmHg and/or DBP >= 120 mmHg, and record the average of the two readings; SBP and/or DBP before randomization must meet the above range standards; 3. Volunteer to participate in this clinical trial and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with ischemic/hemorrhagic stroke and cerebral hemorrhage occurred within 1 month before signing the informed consent form; 2. Patients who have used other antihypertensive drugs within 2 hours before administration; 3. Patients with severe lipid metabolism abnormalities (such as triglycerides > 500 mg/dL familial hypercholesterolemia, lipoid nephropathy, or acute pancreatitis with hyperlipidemia); only use portable blood lipid detectors to detect patients during the screening period The blood lipids of the test subjects, such as triglycerides > 500 mg/dL, cannot be enrolled. The test results of the portable blood lipid detector are recorded as the reference value of blood lipid during the screening period; 4. Patients with known severe hepatic insufficiency or a history of liver failure or cirrhosis; 5. Patients who are known to be intolerant to the study drug or calcium channel blocker and have poor effect, are allergic or allergic to the excipient ingredients of the study drug, or are allergic to soybeans, soy products, eggs and egg products; 6. Patients with known or suspected severe aortic stenosis, or patients with severe mitral stenosis; 7. Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.); 8. Acute coronary syndrome, obstructive hypertrophic cardiomyopathy, and patients with acute myocardial infarction within 1 month before signing the written informed consent; 9. Hypovolemic patients (patients with severe diarrhea, vomiting or other loss of body fluids); 10. Patients with known or suspected aortic syndrome; 11. A history of drug abuse (including methamphetamine, ketamine, cocaine, heroin, cannabis, nitrazepam, methylenedioxy methamphetamine) or alcohol abuse (criteria for symptoms of repeated and excessive use of alcohol causing impairment to physical or/and mental health, with adverse social consequences); Such as inability to complete important work or studies, inability to perform family functions, drunk driving or drunk driving, crime, marital crisis, etc.; The course of disease was defined as two or more times in one year due to alcohol consumption. Excluding alcohol dependence, sedatives, hypnotics and other substance abuse, personality disorders), acute hypertension caused by drug overdose; 12. Pregnant, lactating women or women who are trying to become pregnant, as well as fertile patients (regardless of gender) who cannot accept medically approved contraceptive methods during the trial and within 3 months after the end of the trial; 13. Patients who participated in and used clinical trials of other drugs or devices within 3 months before signing the written informed consent; 14. Patients with previous history of cancer; 15. The patient is combined with other serious large organ damage or serious complications, which may affect life; 16. Those with a history of mental illness; 17. Patients who are considered by the investigator to be inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diastolic blood pressure; | — |
Countries
China
Contacts
Public ContactCao Yu
West China Hospital of Sichuan University
Outcome results
None listed