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Manipulation of Arterial Pressure in Acute Ischemic Stroke (MAPAS)
This study is currently recruiting participants.
Verified by Hospital de Clinicas de Porto Alegre, February 2009
First Received: February 19, 2009   Last Updated: February 26, 2009   History of Changes
Sponsored by: Hospital de Clinicas de Porto Alegre
Information provided by: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00848770
  Purpose

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 Intervention
Stroke, Acute
 Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)
Drug: Esmolol, NPS or NOR
Drug: manipulation of SAP

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability

Resource links provided by NLM:

Drug Information available for: Norepinephrine Esmolol Asl 8052 Norepinephrine bitartrate
U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Ranking score and mortality [ Time Frame: Three month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1, 140 to 160 mmHg: Active Comparator
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.
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
2, 161 to 180 mmHg: Active Comparator
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.
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
3, 181 to 200 mmHg: Active Comparator
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • Shock
  • Acute heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848770

Contacts
Contact: Luiz A Nasi, Physician 55 51 9982 18 44 lnasi@terra.com.br
Contact: Miguel Gus 55 51 81627002 mgus@mgus.com.br

Locations
Brazil, RS
Hospital de Clínicas de Porto Alegre/ UFRGS Recruiting
Porto Alegre, RS, Brazil
Principal Investigator: L A Nasi, Doctor            
Sub-Investigator: M Gus, Doctor            
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Luiz A Nasi, Physician Hospital de Clínicas de Porto Alegre / UFRGS
  More Information

Additional Information:
Clinical trial of Manipulation of Arterial Pressure Early in Acute Ischemic Stroke  This link exits the ClinicalTrials.gov site

Publications:
Potter J, Robinson T, Ford G, James M, Jenkins D, Mistri A, Bulpitt C, Drummond A, Jagger C, Knight J, Markus H, Beevers G, Dewey M, Lees K, Moore A, Paul S; The CHHIPS Trial Group. CHHIPS (Controlling Hypertension and Hypotension Immediately Post-Stroke) Pilot Trial: rationale and design. J Hypertens. 2005 Mar;23(3):649-55. Review.

Responsible Party: GPPG ( Hospital de Clinicas de Porto Alegre )
Study ID Numbers: HCPA 07-470
Study First Received: February 19, 2009
Last Updated: February 26, 2009
ClinicalTrials.gov Identifier: NCT00848770     History of Changes
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:
Stroke, Acute
Systolic Pressure of Blood

Study placed in the following topic categories:
Neurotransmitter Agents
Death
Adrenergic alpha-Agonists
Adrenergic Agents
Cerebral Infarction
Stroke
Vascular Diseases
Benzocaine
Central Nervous System Diseases
Cardiovascular Agents
Ischemia
Brain Diseases
 Cerebrovascular Disorders
Adrenergic Agonists
Esmolol
Norepinephrine
Vasoconstrictor Agents
Adrenergic beta-Antagonists
Brain Ischemia
Adrenergic Antagonists
Peripheral Nervous System Agents
Brain Infarction
Infarction

Additional relevant MeSH terms:
Neurotransmitter Agents
Cerebral Infarction
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Brain Diseases
Cerebrovascular Disorders
Adrenergic Agonists
Therapeutic Uses
Vasoconstrictor Agents
Adrenergic beta-Antagonists
Brain Ischemia
Cardiovascular Diseases
Adrenergic alpha-Agonists
 Sympathomimetics
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions
Esmolol
Autonomic Agents
Norepinephrine
Adrenergic Antagonists
Brain Infarction
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 30, 2009



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