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Manipulation of Arterial Pressure in Acute Ischemic Stroke

NCT ID: NCT00848770

Last Updated: 2009-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Stroke, Acute

Keywords

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Stroke, Acute Systolic Pressure of Blood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1, 140 to 160 mmHg

Esmolol, NPS or NOR

Group Type ACTIVE_COMPARATOR

Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)

Intervention Type DRUG

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

Intervention Type DRUG

We use one of the three drug to manipulate the systolic arterial pressure

manipulation of SAP

Intervention Type DRUG

Esmolol or NPS or NOR

2, 161 to 180 mmHg

Esmolol, NPS or NOR

Group Type ACTIVE_COMPARATOR

Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)

Intervention Type DRUG

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

Intervention Type DRUG

We use one of the three drug to manipulate the systolic arterial pressure

manipulation of SAP

Intervention Type DRUG

Esmolol or NPS or NOR

3, 181 to 200 mmHg

Esmolol, NPS or NOR

Group Type ACTIVE_COMPARATOR

Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)

Intervention Type DRUG

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

Intervention Type DRUG

We use one of the three drug to manipulate the systolic arterial pressure

manipulation of SAP

Intervention Type DRUG

Esmolol or NPS or NOR

Interventions

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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.

Intervention Type DRUG

Esmolol, NPS or NOR

We use one of the three drug to manipulate the systolic arterial pressure

Intervention Type DRUG

manipulation of SAP

Esmolol or NPS or NOR

Intervention Type DRUG

Other Intervention Names

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Esmolol, NPS or NOR Esmolol or NPS or NOR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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GPPG

Principal Investigators

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Luiz A Nasi, Physician

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre / UFRGS

Locations

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Hospital de Clínicas de Porto Alegre/ UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Luiz A Nasi, Physician

Role: CONTACT

Phone: 55 51 9982 18 44

Email: [email protected]

Miguel Gus

Role: CONTACT

Phone: 55 51 81627002

Email: [email protected]

References

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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) Pilot Trial: rationale and design. J Hypertens. 2005 Mar;23(3):649-55. doi: 10.1097/01.hjh.0000160224.94220.e7.

Reference Type RESULT
PMID: 15716709 (View on PubMed)

Related Links

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http://clinicaltrials.gov/ct2/show/NCT00848770

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

Other Identifiers

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HCPA 07-470

Identifier Type: -

Identifier Source: org_study_id