NCT01195350

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 6, 2011

Status Verified

July 1, 2011

Enrollment Period

1.8 years

First QC Date

July 5, 2010

Last Update Submit

July 4, 2011

Conditions

Stroke

Keywords

Ischemic StrokeHemorrhagic StrokeBlood pressureIntensive care

Outcome Measures

Primary Outcomes (1)

  • Death

    1 week

Secondary Outcomes (1)

  • Physical incapacity

    one month

Study Arms (1)

stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute isquemic or hemorragic stroke admitted in ICU.

You may qualify if:

  • hemorrhagic and ischemic
  • admitted in ICU

You may not qualify if:

  • Age below 18 years
  • Subarachnoid hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidades de Terapia Intensiva do Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

StrokeIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Natalia E Furlan, Bacharel

    Faculdade de Medicina de Botucatu

    PRINCIPAL INVESTIGATOR

  • Rodrigo Bassan, MSc

    Faculdade de Medicina de Botucatu

    STUDY CHAIR

  • Luis C Martin, Phd

    Faculdade de Medicina de Botucatu

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2010

First Posted

September 6, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 6, 2011

Record last verified: 2011-07

Locations

BR(1)