Stroke, AcuteMAPASNCT00848770
Manipulation of Arterial Pressure in Acute Ischemic Stroke
A study testing Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Esmolol, NPS or NOR and manipulation of SAP in people with Stroke, Acute, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Esmolol, NPS or NOR and manipulation of SAP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre/ UFRGS
Porto Alegre, Rio Grande do Sul
L A Nasi, Doctor
M Gus, Doctor
About this study
Official title: Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Esmolol, NPS or NOR, manipulation of SAP
- Keywords
- Stroke, Acute, Systolic Pressure of Blood
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)Drug
Also called Esmolol, NPS or 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 NORDrug
We use one of the three drug to manipulate the systolic arterial pressure
manipulation of SAPDrug
Also called Esmolol or NPS or NOR
Esmolol or NPS or NOR
| Study group | Role | What they receive |
|---|---|---|
| 1, 140 to 160 mmHg | Active comparator | Esmolol, NPS or NOR Receives: 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 Receives: 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 Receives: Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR); Drug: Esmolol, NPS or NOR; Drug: manipulation of SAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ranking score and mortality
Measured: Three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Luiz A Nasi, Physician, Principal investigator, Hospital de Clínicas de Porto Alegre / UFRGS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848770
- Sponsor's protocol ID
- HCPA 07-470
- Acronym
- MAPAS
- Status last verified
- Feb 2009
- First submitted
- 19 Feb 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15716709
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
- ClinicalTrials.gov ID
- NCT00848770
- Acronym / sponsor ID
- MAPAS / HCPA 07-470
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Acute, Systolic Pressure of Blood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1, 140 to 160 mmHg | Active comparator | Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Drug: Esmolol, NPS or NOR, Drug: manipulation of SAPEsmolol, NPS or NOR |
| 2, 161 to 180 mmHg | Active comparator | Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Drug: Esmolol, NPS or NOR, Drug: manipulation of SAPEsmolol, NPS or NOR |
| 3, 181 to 200 mmHg | Active comparator | Drug: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Drug: Esmolol, NPS or NOR, Drug: manipulation of SAPEsmolol, NPS or NOR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR)Also: Esmolol, NPS or NOREsmolol(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. | Drug | 1, 140 to 160 mmHg, 2, 161 to 180 mmHg, 3, 181 to 200 mmHg |
| Esmolol, NPS or NORWe use one of the three drug to manipulate the systolic arterial pressure | Drug | 1, 140 to 160 mmHg, 2, 161 to 180 mmHg, 3, 181 to 200 mmHg |
| manipulation of SAPAlso: Esmolol or NPS or NOREsmolol or NPS or NOR | Drug | 1, 140 to 160 mmHg, 2, 161 to 180 mmHg, 3, 181 to 200 mmHg |
Primary outcome
Ranking score and mortality
Time frame: Three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2009.
- Results publication: PubMed 15716709Potter 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.
- Clinical trial of Manipulation of Arterial Pressure Early in Acute Ischemic StrokeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz A Nasi, Physician principal investigator
Hospital de Clínicas de Porto Alegre / UFRGS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR), Esmolol, NPS or NOR and manipulation of SAP in people with Stroke, Acute, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz A Nasi, Physician (55 51 9982 18 44, lnasi@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ranking score and mortality (time frame: Three month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2009.