PRESSURE is a multicenter, prospective, randomized, open, blinded end-point assessed (PROBE) trial, that aims to evaluate the efficacy and safety of drug-induced hypertension using peripheral dilute norepinephrine, in patients with acute ischemic stroke in a perforating artery territory and experiencing early neurological deterioration.
Perforating artery strokes represent 25% of all ischemic strokes and is a well-known cause of progressive symptoms : 12 to 36% of cases experience early neurological deterioration in hours or days after stroke onset. A possible mechanism is hypoperfusion due to lack of a rapid development of collateral flow because of the terminal distribution of perforating arteries. Moreover, arterioles are maximally dilated within penumbra region, resulting in a cerebral autoregulation failure and a passive dependence of cerebral blood flow on arterial pressure. Thus, induced-hypertension therapy by using vasopressive agents is an attractive therapy to increase the cerebral perfusion pressure and therefore restore blood flow in the ischemic penumbra.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
358
Norepinephrine (dilution: 10µg/ml, initial dose: 0.04µg/kg/min) will be titrated until MAP is between 110 and 120mmHG (with a maximal systolic blood pressure of 210mmHG) Gradually decrease of norepinephrine will start after 24h of NIHSS stabilization.
CHU de Bordeaux
Bordeaux, France
RECRUITINGmodified Rankin Scale (mRS)
Functional independence defined by modified Rankin scale 0-2 or return to pre-stroke modified Rankin scale, assessed at 90 days. The assessment of the clinical outcome at 90 (±15) days will be conducted by an independent qualified assessor (blinded to patient treatment allocation). The minimal value of the modified Rankin Scale is 0 (best outcome) and the maximum value is 6 (worst outcome).
Time frame: Day 0
modified Rankin Scale (mRS)
Functional independence defined by modified Rankin scale 0-2 or return to pre-stroke modified Rankin scale, assessed at 90 days. The assessment of the clinical outcome at 90 (±15) days will be conducted by an independent qualified assessor (blinded to patient treatment allocation). The minimal value of the modified Rankin Scale is 0 (best outcome) and the maximum value is 6 (worst outcome).
Time frame: Day 90
modified Rankin Scale (mRS)
Functional outcomes as measured through the ordinal (shift) modified Rankin scale. The minimal value of the modified Rankin Scale is 0 (best outcome) and the maximum value is 6 (worst outcome).
Time frame: Day 90
modified Rankin Scale (mRS)
Functional outcomes as measured through the rate of 90-day excellent functional outcome (mRS 0-1). The minimal value of the modified Rankin Scale is 0 (best outcome) and the maximum value is 6 (worst outcome).
Time frame: Day 90
NIHSS Score
c. Early neurological improvement defined as a reduction (compared to the NIHSS at the time of randomization) of at least 3 points or a score of 0 or 1 on the NIHSS
Time frame: Day 0
NIHSS Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Early neurological improvement defined as a reduction (compared to the NIHSS at the time of randomization) of at least 3 points or a score of 0 or 1 on the NIHSS
Time frame: Day 7
Mortality
Time frame: Day 90
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
The minimum value of the PC-PTSD-5 is 0 (best outcome) and the maximum value is 5 (worst outcome)
Time frame: Day 90
Hospital Anxiety and Depression Scale
The HAD scale provides 2 sub-scores, one on depression, and one on anxiety. Both sub-scores range from 0 (best outcome) to 21 (worst outcome)
Time frame: Day 90
Proportion of patients presenting Acute coronary syndrome
Acute Coronary Syndrome refers to ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina. We will estimate the proportion of patients presenting at least one of these events until day 7.
Time frame: Day 7
Proportion of patients presenting Congestive heart failure
We will estimate the proportion of patients presenting at least one episode of congestive heart failure until day 7.
Time frame: Day 7
Proportion of patients presenting Tachyarrhythmia
Tachyarrythmia refers to a resting heart rate that exceeds 100 beats per minute. We will estimate the proportion of patients presenting at least one episode of tachyarrythmia until day 7.
Time frame: Day 7