Manipulation of Arterial Pressure in Acute Ischemic Stroke

NCT00848770 | Unknown

• 1 other identifier: HCPA 07-470
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

Stroke, Acute; Systolic Pressure of Blood

Outcome Measures

Primary Outcomes (1)

• Ranking score and mortality

  Three month

Study Arms (3)

1, 140 to 160 mmHg

ACTIVE COMPARATOR

Esmolol, NPS or NOR

Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); Drug: Esmolol, NPS or NOR; Drug: manipulation of SAP

2, 161 to 180 mmHg

ACTIVE COMPARATOR

Esmolol, NPS or NOR

Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); Drug: Esmolol, NPS or NOR; Drug: manipulation of SAP

3, 181 to 200 mmHg

ACTIVE COMPARATOR

Esmolol, NPS or NOR

Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); Drug: Esmolol, NPS or NOR; Drug: manipulation of SAP

Interventions

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

Also known as: Esmolol, NPS or NOR

1, 140 to 160 mmHg; 2, 161 to 180 mmHg; 3, 181 to 200 mmHg

Esmolol, NPS or NOR DRUG

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

1, 140 to 160 mmHg; 2, 161 to 180 mmHg; 3, 181 to 200 mmHg

manipulation of SAP DRUG

Esmolol or NPS or NOR

Also known as: Esmolol or NPS or NOR

1, 140 to 160 mmHg; 2, 161 to 180 mmHg; 3, 181 to 200 mmHg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre/ UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

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

  PMID: 15716709 RESULT

Related Links

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

MeSH Terms

Conditions

Stroke

Interventions

esmolol; Norepinephrine; Nucleolus Organizer Region

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chromosome Structures; Genetic Structures; Genetic Phenomena; Genetic Loci; Genome Components; Genome

Study Officials

• Luiz A Nasi, Physician

  Hospital de Clínicas de Porto Alegre / UFRGS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz A Nasi, Physician

CONTACT

55 51 9982 18 44; lnasi@terra.com.br

Miguel Gus

CONTACT

55 51 81627002; mgus@mgus.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 31, 2009

Record last verified: 2009-02

Locations

BR (1)