MAPAS: Manipulation of Arterial Pressure in Acute Ischemic Stroke

• Sponsor: Hospital de Clinicas de Porto Alegre (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00848770
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 3
• Duration (Months): 35
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); Drug: Esmolol, NPS or NOR; Drug: manipulation of SAP	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
• Study Start Date: Jan 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1, 140 to 160 mmHg Esmolol, NPS or NOR	Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); 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.; Other Names: Esmolol, NPS or NOR ; Drug: Esmolol, NPS or NOR; We use one of the three drug to manipulate the systolic arterial pressure; Drug: manipulation of SAP; Esmolol or NPS or NOR; Other Names: Esmolol or NPS or NOR
Active Comparator: 2, 161 to 180 mmHg Esmolol, NPS or NOR	Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); 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.; Other Names: Esmolol, NPS or NOR ; Drug: Esmolol, NPS or NOR; We use one of the three drug to manipulate the systolic arterial pressure; Drug: manipulation of SAP; Esmolol or NPS or NOR; Other Names: Esmolol or NPS or NOR
Active Comparator: 3, 181 to 200 mmHg Esmolol, NPS or NOR	Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); 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.; Other Names: Esmolol, NPS or NOR ; Drug: Esmolol, NPS or NOR; We use one of the three drug to manipulate the systolic arterial pressure; Drug: manipulation of SAP; Esmolol or NPS or NOR; Other Names: Esmolol or NPS or NOR

Outcome Measures

Primary Outcome Measures

1. Ranking score and mortality [Three month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clínicas de Porto Alegre/ UFRGS	Porto Alegre	RS	Brazil

Sponsors and Collaborators

• Hospital de Clinicas de Porto Alegre

Investigators

• Principal Investigator: Luiz A Nasi, Physician, Hospital de Clínicas de Porto Alegre / UFRGS

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial of Manipulation of Arterial Pressure Early in Acute Ischemic Stroke

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00848770
• Other Study ID Numbers: HCPA 07-470
• First Posted: Feb 20, 2009
• Last Update Posted: Dec 31, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Stroke, Acute; Systolic Pressure of Blood
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Norepinephrine; Esmolol

Study Results

No Results Posted as of Dec 31, 2009