Name:
Celine Gathier
Department of Neurology and Department of Intensive Care
Section Cerebrovascular disorders
Function:
PhD-student
E-mail:
c.s.gathier-2@umcutrecht.nl
Tel: +31 88-7561124
Pager: # 11 4469
Supervisor:
A.J.C. Slooter and G.J.E. Rinkel
Title research: Induced hypertension for treatment of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.
Summary research:
Background Subarachnoid haemorrhage (SAH) from a ruptured cerebral aneurysm is a subset of stroke with a poor prognosis. Delayed cerebral ischemia (DCI) is a major complication after SAH in around 30% of SAH patients and increases case fatality 1.5 – 3 fold. Many centres around the world use induced hypertension, alone or in combination with hemodilution and hypervolemia, so called Triple-H, as standard therapy in the treatment of DCI, but the efficacy of induced hypertension in reducing DCI is based on case series only, and not on a randomised clinical trial.
Objective To investigate the outcome after induced hypertension versus no induced hypertension in patients with DCI after aneurysmal SAH.
Study design A multi-centre, single blinded, randomized controlled trial.
Study population
Patients admitted to one of the participating centres after recent SAH with a treated aneurysm and DCI based on the onset of a new focal deficit and/or a decrease of the level of consciousness of at least 1 point of the Glasgow Coma Scale with exclusion of other causes of deterioration, will be randomized to either hypertension (n=120) or no hypertension (n=120).
Interventions
Patients in the intervention group will have their blood pressure raised with norepinephrine in order to improve cerebral blood flow (CBF). In case of a low cardiac output, dobutamin will be added. Induced hypertension will be continued for at least 48 hours when patients show some improvement within the first 24 hours. After 48 hours, the dose norepinephrine will be tapered daily, and resumed in case of clinical deterioration. In patients who do not show any improvement within 24 hours, of which at least 6 hours at a maximum dose, induced hypertension will not be continued.
Patients in the reference group will be treated according to the standardised SAH treatment protocol of the participating centre including oral nimodipine and normovolaemia without haemodilution.
Main outcome measurement
The modified Rankin scale at 3 months after the SAH, will be compared between patients who were randomized to induced hypertension and patients who were randomized to no induced hypertension.