Manipulation of Arterial Pressure in Acute Ischemic Stroke "MAPAS"

Recruiting

Phase N/A Results N/A

Trial Description

This is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to determine the effects of three levels of arterial pressure on death and neurological disability. After the admission in the vascular unit of the Emergency Department the patients are randomized to maintain during the first 24h the Systolic Arterial Pressure in tree levels of pressure: 140 to 160 mmHg; 161 to 180 mmHg and 181 to 200 mmHg. The end point of the study is the Modified Rankin score and mortality in three month after the discharge.

Detailed Description

To maintain the tree levels of systolic arterial pressure during de first 24h we will use one of the two strategies:1) infusion of 500 to 1000ml of saline solution and/or norepinephrine solution to increase de systolic pressure or 2) infusion of esmolol or nitroprussiate solution to decrease de pressure. Every patient will have a transcranial doppler study in the first 24h to measure the mean velocity of cerebral arteries.

Conditions

Interventions

  • Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR) Drug
    Other Names: Esmolol, NPS or NOR
    Intervention Desc: Esmolol(2,5g /10ml + SG5% 240ml = 10mg/ml). Start with a bolus of 500mcg/kg in 1 min (ou 0,5mg/kg)and maintain the dose of 50mcg/kg/min (or 0,05mg/kg/min). Increase de infusion in 25mcg/kg/min after each 5 min until the randomized SAP or if the heart beat is lower than 60. The maximum dose is 200ug/kg/min (ou 0,2 mg/kg/min). If the randomized SAP do not reach the goal pressure with the maximum dose of esmolol, start a infusion of sodium nitroprussiate (NPS). NPS (50mg + SG5% 250ml= 200mcg/ml). No bolus. Start the infusion with 0,2 mcg/kg/min and maintain 0,5 a 5mcg/kg/min. Increase de dose each 15 min to a maximum of 10mcg/kg/min. NOR: (8mg/8ml + SG5% 242ml=32mcg/ml)No bolus. Start 1 to 5 mcg/min to a maximum dose of 20mcg/min.
    ARM 1: Kind: Experimental
    Label: 1, 140 to 160 mmHg
    Description: Esmolol, NPS or NOR
    ARM 2: Kind: Experimental
    Label: 2, 161 to 180 mmHg
    Description: Esmolol, NPS or NOR
    ARM 3: Kind: Experimental
    Label: 3, 181 to 200 mmHg
    Description: Esmolol, NPS or NOR
  • Esmolol, NPS or NOR Drug
    Other Names: Esmolol, NPS or NOR
    Intervention Desc: We use one of the three drug to manipulate the systolic arterial pressure
    ARM 1: Kind: Experimental
    Label: 1, 140 to 160 mmHg
    Description: Esmolol, NPS or NOR
    ARM 2: Kind: Experimental
    Label: 2, 161 to 180 mmHg
    Description: Esmolol, NPS or NOR
    ARM 3: Kind: Experimental
    Label: 3, 181 to 200 mmHg
    Description: Esmolol, NPS or NOR
  • Manipulation of SAP Drug
    Other Names: Esmolol or NPS or NOR
    Intervention Desc: Esmolol or NPS or NOR
    ARM 1: Kind: Experimental
    Label: 1, 140 to 160 mmHg
    Description: Esmolol, NPS or NOR
    ARM 2: Kind: Experimental
    Label: 2, 161 to 180 mmHg
    Description: Esmolol, NPS or NOR
    ARM 3: Kind: Experimental
    Label: 3, 181 to 200 mmHg
    Description: Esmolol, NPS or NOR

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ranking score and mortality Three month Yes

Sponsors