Manipulation of Arterial Pressure in Acute Ischemic Stroke

Stroke, Acute Clinical Trial

— MAPAS  

Official title:

Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00848770
• Other study ID #: HCPA 07-470
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2009
• Last updated: December 30, 2009
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Luiz A Nasi, Physician
• Phone: 55 51 9982 18 44
• Email: lnasi[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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.
• Esmolol, NPS or NOR
We use one of the three drug to manipulate the systolic arterial pressure
• manipulation of SAP
Esmolol or NPS or NOR

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre/ UFRGS	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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; CHHIPS Trial Group. CHHIPS (Controlling Hypertension and Hypotension Immediately Post-Stroke) Pil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ranking score and mortality		Three month	Yes

External Links

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