Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage; Hypertension
MeSH terms: Subarachnoid Hemorrhage; Hypertension; Hemorrhage
Intervention: Clevidipine butyrate injectable emulsion
Intervention description: Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.
Intervention MeSH terms: Clevidipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Subarachnoid hemorrhage; Hypertension; brain Aneurysm; intracerebral hemorrhage; antihypertensive; calcium channel blockers; infusion; neurocritical care

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.
    

Eligibility 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