Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
Overview
- Phase
- Not Applicable
- Intervention
- Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)
- Conditions
- Stroke, Acute
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Ranking score and mortality
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 18 years or older, with the first Acute Ischemic Stroke within the first 6 hours of the symptoms and not candidate to thrombolysis
- •We will also include patients with previous Ischemic Stroke with Ranking score 0 or 1
Exclusion Criteria
- •Improuvment of the symptoms rapidly (in the first 15 min after admission)
- •Seizures not related do the acute ischemic stroke
- •Previous ischemic stroke in the last 6 weeks and with Ranking score \> 1
- •Haemorrhagic stroke
- •Anticoagulation
- •Hypoglycemia
- •Acute heart failure
Arms & Interventions
1, 140 to 160 mmHg
Esmolol, NPS or NOR
Intervention: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)
1, 140 to 160 mmHg
Esmolol, NPS or NOR
Intervention: Esmolol, NPS or NOR
1, 140 to 160 mmHg
Esmolol, NPS or NOR
Intervention: manipulation of SAP
2, 161 to 180 mmHg
Esmolol, NPS or NOR
Intervention: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)
2, 161 to 180 mmHg
Esmolol, NPS or NOR
Intervention: Esmolol, NPS or NOR
2, 161 to 180 mmHg
Esmolol, NPS or NOR
Intervention: manipulation of SAP
3, 181 to 200 mmHg
Esmolol, NPS or NOR
Intervention: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)
3, 181 to 200 mmHg
Esmolol, NPS or NOR
Intervention: Esmolol, NPS or NOR
3, 181 to 200 mmHg
Esmolol, NPS or NOR
Intervention: manipulation of SAP
Outcomes
Primary Outcomes
Ranking score and mortality
Time Frame: Three month