Manipulation of Arterial Pressure in Acute Ischemic Stroke
Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke, Acute
Intervention: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR) (Drug); Esmolol, NPS or NOR (Drug); manipulation of SAP (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hospital de Clinicas de Porto Alegre Official(s) and/or principal investigator(s): Luiz A Nasi, Physician, Principal Investigator, Affiliation: Hospital de Clínicas de Porto Alegre / UFRGS
Overall contact: Luiz A Nasi, Physician, Phone: 55 51 9982 18 44, Email: lnasi@terra.com.br
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.
Clinical Details
Official title: Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ranking score and mortality
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Luiz A Nasi, Physician, Phone: 55 51 9982 18 44, Email: lnasi@terra.com.br
Hospital de Clínicas de Porto Alegre/ UFRGS, Porto Alegre, RS, Brazil; Recruiting L A Nasi, Doctor, Principal Investigator M Gus, Doctor, Sub-Investigator
Additional Information
Clinical trial of Manipulation of Arterial Pressure Early in Acute Ischemic Stroke
Starting date: January 2008
Last updated: December 30, 2009
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