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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, 140 to 160 mmHg | Active Comparator | Esmolol, NPS or NOR |
|
| 2, 161 to 180 mmHg | Active Comparator | Esmolol, NPS or NOR |
|
| 3, 181 to 200 mmHg | Active Comparator | Esmolol, NPS or NOR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ranking score and mortality | Three month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz A Nasi, Physician | Contact | 55 51 9982 18 44 | lnasi@terra.com.br | |
| Miguel Gus | Contact | 55 51 81627002 | mgus@mgus.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Luiz A Nasi, Physician | Hospital de ClÃnicas de Porto Alegre / UFRGS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre/ UFRGS | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15716709 | Result | 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. |
| Label | URL |
|---|---|
| Clinical trial of Manipulation of Arterial Pressure Early in Acute Ischemic Stroke | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D009638 | Norepinephrine |
| D009697 | Nucleolus Organizer Region |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| Esmolol, NPS or NOR | Drug | We use one of the three drug to manipulate the systolic arterial pressure |
|
| manipulation of SAP | Drug | Esmolol or NPS or NOR |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D022004 | Chromosome Structures |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D056426 | Genetic Loci |
| D040481 | Genome Components |
| D016678 | Genome |