Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Control of blood pressure is of high value in preventing this balloon that ruptured and bled from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical procedure. Clevidipine is a drug that can lower blood pressure and it is given through the vein as a continuous infusion. It is a very short acting drug which is important in controlling labile blood pressure condition with rapid changes between up and down. This trial will test for its rapid actions and check for any side effects and possibly any other potential benefit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Collaborator: The Medicines Company
• Treatments: Butyric Acid; Clevidipine

Criteria

Inclusion Criteria:

1. Diagnosis of SAH

2. Presence of unsecured aneurysm

3. Patient age between 18 and 80 years

4. Hunt and Hess grade <5 (non-sedated-paralyzed pt)

5. Glasgow Coma scale >4 (non-sedated-paralyzed pt)

6. BP above the pre-specified upper limit set by MD

7. Patient has not received pressors or inotropes

8. Patient has not received IV anti-hypertensives for more than 5 minutes (sodium nitroprusside infusion should be stopped as clevidipine is started

9. Patient has given informed consent

Exclusion Criteria:

1. Patient is <18 or >80 years of age

2. Patient has Traumatic SAH

3. Patient has Perimesencephalic SAH

4. Hunt and Hess grade 5 (deeply comatose/ brain dead)

5. Glasgow Coma scale 3 or 4 (deeply comatose/brain dead)

6. Patient on pressors or anti-hypertensives for more than 5 minutes

7. SBP < 90 mm Hg

8. Heart rate >110

9. Patient with Left BBB

10. Patient with a permanent ventricular pacemaker

11. Known allergy to dihydropyridines or clevidipine

12. Known allergy to soy products, beans, eggs or egg products22. Patients with defective lipid metabolism or pathologic hyperlipidemia or lipid nephrosis

13. Acute pancreatitis, accompanied by hyperlipidemia

14. Severe aortic stenosis

15. Pregnancy