StrokeNCT01195350
Blood Pressure Level and Prognosis in Acute Stroke
An observational study of Stroke, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic phase is the major measure to primary and secondary prevention, but in acute phase is not clear the best blood pressure level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 266 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Dec 2011
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Acute isquemic or hemorragic stroke admitted in ICU.
Who may be able to join
- hemorrhagic and ischemic
- admitted in ICU
Who cannot join
- Age below 18 years
- Subarachnoid hemorrhage
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Unidades de Terapia Intensiva do Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo
Natalia Furlan, na-furlan@hotmail.com
About this study
Official title: Relationship Between Blood Pressure Level and Lethality in Acute Phase of Stroke : Observational Prospective Study.
Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic phase is the major measure to primary and secondary prevention, but in acute phase is not clear the best blood pressure level. Few studies demonstrate a "U" relationship between blood pressure and lethality; nevertheless any Brazilian study has addressed this issue.
This is a prospective observational study on the relationship between BP and mortality in the acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP. Will be analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of hemorrhagic and ischemic stroke. Participants will be divided into three groups according to the initial PA present:
Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180 mmHg entry. Multiple logistic regression analysis will be done to verify the association of blood pressure and lethality adjusted to confounding variables.
Read the detailed description
Relation between blood pressure and lethality in stroke: observational study.
Introduction:
Stroke is the leading cause of death and disabling sequelae in adults in Brazil (LESSA, 1999), and the 2nd cause in the world (GRYSIEWICZ \& al. 2008).
Arterial hypertension (AH) is the major risk factor for the occurrence of stroke. It is estimated that about 70% of all strokes are caused by uncontrolled hypertension (RADANOVIC, 2000). BP control is a key priority in the prevention of Stroke, but unfortunately, the rule that: among all hypertensive, only half is known of its hypertension, among those who know only half is in treatment, and half among them are in appropriate levels of BP, still valid (GUYTON \& HALL, 2002).
Several studies were conducted as patients without prior stroke or in the stable phase of stroke (FRISHMAN \& col. 1991; CHAPMAN \& col. 2001; LENNART \& col. 1998), but few studies evaluated patients in acute phase of stroke. Blood pressure (BP) during this phase aggravates cerebral edema (SPENCE, 2009), facilitates hemorrhagic transformation (BOWES \& col. 1996; SAKU \& col. 1990 and SAGAN et al 1998) which is the development of a cerebral hematoma at the site of cerebral ischemia and provides initial acute damage in other target organs: kidneys, heart and vessels (VELASCO \& col. 1994). All these complications lead to increased mortality in the acute phase of stroke.
Both hemorrhagic and the ischemic stroke are associated with high BP. Several international studies stroke identified a form of "U" in the relationship between BP and mortality, so that PA high or too low is associated with increased early or late death in patients with stroke (GEEGANAGE \& BATH, 2009). Studies: International Stroke Trial (LEONARDI \& col. 2002); CHHIPS (POTTER \& col. 2005), and the researchers TIKHONOFF \& col.(2009); VEMMA \& col. (2004); BOREAS \& col. (2002); CARLBERG \& col. (1993) showed this relationship in "U".
Thus, further studies are needed to define the role of the PA's relationship with mortality in the acute phase of stroke. Moreover, it is important to note that in Brazil there is no description of studies that investigated this relationship.
Methods Type of study This is a prospective observational study on the relationship between BP and mortality in the acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP: ICU Emergency Room, which currently has nine beds, and ICU Central, which currently has 15 beds. These units are classified as level III according to the Ministry of Health, and attend various specialties.
Inclusion and exclusion Will be analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of hemorrhagic and ischemic stroke. Shall be excluded patients with subarachnoid hemorrhage.
Variables to be evaluated Will be assessed the APACHE II, the modified Rankin scale, international scale the stroke of the National Institute of Health (NIH, 2009) and the value of AP at admission of patients. The PA will be evaluated throughout the first week. The Rankin will be analyzed in one and four weeks after onset of symptoms in survivors. Will be evaluated temperature, capillary glucose, creatinine, urine I, uric acid, hemoglobin, complete lipid profile, medications used prior to and during the observation period of seven days after the stroke. The history of diabetes, history of hypertension and smoking are also recorded.
The APACHE II will be evaluated within the first 24 hours of hospitalization in ICU, to assess the risk of death and prognosis of patients (CHIAVONE, 2003).
The modified Rankin scale evaluates the patient's motor function after stroke (FABIO \& col. 2009). This scale will be assessed at the time of closure of the blood pressure reading (seven days) and after four weeks.
The severity of stroke will be assessed by the international scale of the NIH stroke will be assessed at the beginning of admission, which assesses the effect of acute stroke in level of consciousness, language, neglect, visual field loss, eye movement, muscle strength, ataxia , dysarthria and sensory loss (NIH 2010).
Will be held the medical records of patients with stroke in acute phase, verified and recorded the values of all the PAs presented by patients, for a maximum of seven days (or as discharge or death). The values of temperature and blood glucose monitoring will also be recorded. Will be recorded signs and symptoms of stroke and duration of each clinical data. It will be noted that the stroke thrombolysis was performed or not.
The BP measurement, noninvasive, will take place with the aid of a multiparametric monitor with pressure cuff noninvasive, positioned in the patient's arm, inflated with automatic and programmable. This measure will be evaluated with the usual frequency of monitoring in the ICU, which is: every two hours in stable cases and with greater frequency as the case requires.
Data collection takes place only after informed consent of the person responsible for the patient. Will be evaluated only cases where the responsible parties signing the consent form. Patients who, in their evolution, regain consciousness enough to give informed consent will be required to do so.
Groups
Participants will be divided into three groups according to the initial PA present:
Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180 mmHg entry.
Data Analysis Sample size: the number of individuals in the sample is 266 patients. This number was calculated to detect 20% difference in mortality with an alpha error of 0.05 and statistical power of 0.8.
The data will be analyzed using descriptive statistics and application of chi-square to determine the frequency difference in mortality between the groups. The baseline characteristics of the groups will be compared by analysis of variance or chi-square when appropriate. The variables that differ with p <0.1 will form multiple logistic regression analysis taking as dependent variable patient outcome and adjust the effect of blood pressure for confounding variables. The primary outcome will be death and secondary to the degree of dependence measured by modified Rankin scale.
- Conditions
- Stroke
- Keywords
- Ischemic Stroke, Hemorrhagic Stroke, Blood pressure, Intensive care
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stroke | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 1 week
Secondary outcomes (1)
Physical incapacity
Modified Rankin scale will be applied within one month after the cerebrovascular event.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Natalia E Furlan, Bacharel, Principal investigator, Faculdade de Medicina de BotucatuRodrigo Bassan, MSc, Study chair, Faculdade de Medicina de BotucatuLuis C Martin, Phd, Study director, Faculdade de Medicina de Botucatu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195350
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-47
- Status last verified
- Jul 2011
- First submitted
- 5 Jul 2010
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Blood Pressure Level and Lethality in Acute Phase of Stroke : Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT01195350
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-47
- Conditions
- Stroke
- Keywords
- Ischemic Stroke, Hemorrhagic Stroke, Blood pressure, Intensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 Sep 2010 (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.
Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic phase is the major measure to primary and secondary prevention, but in acute phase is not clear the best blood pressure level. Few studies demonstrate a "U" relationship between blood pressure and lethality; nevertheless any Brazilian study has addressed this issue.
This is a prospective observational study on the relationship between BP and mortality in the acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP. Will be analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of hemorrhagic and ischemic stroke. Participants will be divided into three groups according to the initial PA present:
Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180 mmHg entry. Multiple logistic regression analysis will be done to verify the association of blood pressure and lethality adjusted to confounding variables.
Detailed description
Relation between blood pressure and lethality in stroke: observational study.
Introduction:
Stroke is the leading cause of death and disabling sequelae in adults in Brazil (LESSA, 1999), and the 2nd cause in the world (GRYSIEWICZ \& al. 2008).
Arterial hypertension (AH) is the major risk factor for the occurrence of stroke. It is estimated that about 70% of all strokes are caused by uncontrolled hypertension (RADANOVIC, 2000). BP control is a key priority in the prevention of Stroke, but unfortunately, the rule that: among all hypertensive, only half is known of its hypertension, among those who know only half is in treatment, and half among them are in appropriate levels of BP, still valid (GUYTON \& HALL, 2002).
Several studies were conducted as patients without prior stroke or in the stable phase of stroke (FRISHMAN \& col. 1991; CHAPMAN \& col. 2001; LENNART \& col. 1998), but few studies evaluated patients in acute phase of stroke. Blood pressure (BP) during this phase aggravates cerebral edema (SPENCE, 2009), facilitates hemorrhagic transformation (BOWES \& col. 1996; SAKU \& col. 1990 and SAGAN et al 1998) which is the development of a cerebral hematoma at the site of cerebral ischemia and provides initial acute damage in other target organs: kidneys, heart and vessels (VELASCO \& col. 1994). All these complications lead to increased mortality in the acute phase of stroke.
Both hemorrhagic and the ischemic stroke are associated with high BP. Several international studies stroke identified a form of "U" in the relationship between BP and mortality, so that PA high or too low is associated with increased early or late death in patients with stroke (GEEGANAGE \& BATH, 2009). Studies: International Stroke Trial (LEONARDI \& col. 2002); CHHIPS (POTTER \& col. 2005), and the researchers TIKHONOFF \& col.(2009); VEMMA \& col. (2004); BOREAS \& col. (2002); CARLBERG \& col. (1993) showed this relationship in "U".
Thus, further studies are needed to define the role of the PA's relationship with mortality in the acute phase of stroke. Moreover, it is important to note that in Brazil there is no description of studies that investigated this relationship.
Methods Type of study This is a prospective observational study on the relationship between BP and mortality in the acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP: ICU Emergency Room, which currently has nine beds, and ICU Central, which currently has 15 beds. These units are classified as level III according to the Ministry of Health, and attend various specialties.
Inclusion and exclusion Will be analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of hemorrhagic and ischemic stroke. Shall be excluded patients with subarachnoid hemorrhage.
Variables to be evaluated Will be assessed the APACHE II, the modified Rankin scale, international scale the stroke of the National Institute of Health (NIH, 2009) and the value of AP at admission of patients. The PA will be evaluated throughout the first week. The Rankin will be analyzed in one and four weeks after onset of symptoms in survivors. Will be evaluated temperature, capillary glucose, creatinine, urine I, uric acid, hemoglobin, complete lipid profile, medications used prior to and during the observation period of seven days after the stroke. The history of diabetes, history of hypertension and smoking are also recorded.
The APACHE II will be evaluated within the first 24 hours of hospitalization in ICU, to assess the risk of death and prognosis of patients (CHIAVONE, 2003).
The modified Rankin scale evaluates the patient's motor function after stroke (FABIO \& col. 2009). This scale will be assessed at the time of closure of the blood pressure reading (seven days) and after four weeks.
The severity of stroke will be assessed by the international scale of the NIH stroke will be assessed at the beginning of admission, which assesses the effect of acute stroke in level of consciousness, language, neglect, visual field loss, eye movement, muscle strength, ataxia , dysarthria and sensory loss (NIH 2010).
Will be held the medical records of patients with stroke in acute phase, verified and recorded the values of all the PAs presented by patients, for a maximum of seven days (or as discharge or death). The values of temperature and blood glucose monitoring will also be recorded. Will be recorded signs and symptoms of stroke and duration of each clinical data. It will be noted that the stroke thrombolysis was performed or not.
The BP measurement, noninvasive, will take place with the aid of a multiparametric monitor with pressure cuff noninvasive, positioned in the patient's arm, inflated with automatic and programmable. This measure will be evaluated with the usual frequency of monitoring in the ICU, which is: every two hours in stable cases and with greater frequency as the case requires.
Data collection takes place only after informed consent of the person responsible for the patient. Will be evaluated only cases where the responsible parties signing the consent form. Patients who, in their evolution, regain consciousness enough to give informed consent will be required to do so.
Groups
Participants will be divided into three groups according to the initial PA present:
Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180 mmHg entry.
Data Analysis Sample size: the number of individuals in the sample is 266 patients. This number was calculated to detect 20% difference in mortality with an alpha error of 0.05 and statistical power of 0.8.
The data will be analyzed using descriptive statistics and application of chi-square to determine the frequency difference in mortality between the groups. The baseline characteristics of the groups will be compared by analysis of variance or chi-square when appropriate. The variables that differ with p <0.1 will form multiple logistic regression analysis taking as dependent variable patient outcome and adjust the effect of blood pressure for confounding variables. The primary outcome will be death and secondary to the degree of dependence measured by modified Rankin scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute isquemic or hemorragic stroke admitted in ICU.
Key inclusion criteria (2 listed)
- hemorrhagic and ischemic
- admitted in ICU
Key exclusion criteria (2 listed)
- Age below 18 years
- Subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 1 week
1 secondary outcome
Physical incapacity
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
Unidades de Terapia Intensiva do Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, Brazil
Natalia E Furlan, Bacharel principal investigator
Faculdade de Medicina de Botucatu
Rodrigo Bassan, MSc study chair
Faculdade de Medicina de Botucatu
Luis C Martin, Phd study director
Faculdade de Medicina de Botucatu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by UPECLIN HC FM Botucatu Unesp 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 2 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 6 Jul 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2011.