Manipulation of Arterial Pressure in Acute Ischemic Stroke

Not Applicable

• Conditions: Stroke, Acute
• Interventions: Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); Drug: Esmolol, NPS or NOR; Drug: manipulation of SAP

• Registration Number: NCT00848770
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-02
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Last Update Submitted: 2009-12-30
• Last Update Posted: 2009-12-31
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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
• Shock
• Acute heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2, 161 to 180 mmHg	Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)	Esmolol, NPS or NOR
3, 181 to 200 mmHg	Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)	Esmolol, NPS or NOR
1, 140 to 160 mmHg	Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)	Esmolol, NPS or NOR
1, 140 to 160 mmHg	Esmolol, NPS or NOR	Esmolol, NPS or NOR
1, 140 to 160 mmHg	manipulation of SAP	Esmolol, NPS or NOR
2, 161 to 180 mmHg	Esmolol, NPS or NOR	Esmolol, NPS or NOR
2, 161 to 180 mmHg	manipulation of SAP	Esmolol, NPS or NOR
3, 181 to 200 mmHg	Esmolol, NPS or NOR	Esmolol, NPS or NOR
3, 181 to 200 mmHg	manipulation of SAP	Esmolol, NPS or NOR

Primary Outcome Measures

Name	Time	Method
Ranking score and mortality	Three month

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre/ UFRGS; 🇧🇷 Porto Alegre, RS, Brazil