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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00848770
Other study ID # HCPA 07-470
Secondary ID
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


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
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