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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04434287
Other study ID # REAVC ( 29BRC20.0062)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 12, 2020
Est. completion date June 29, 2020

Study information

Verified date April 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).

The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date June 29, 2020
Est. primary completion date June 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- acute stroke

- ICU admission for acute stroke

- 1 organ dysfunction : coma, shock, respiratory failure

Exclusion Criteria:

- refuse participation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality through ICU hospitalization, an average of one month
Secondary Mortality Mortality At 90 days
Secondary Functional outcome: Modified Rankin Score Modified Rankin Score (0: no symptoms at all; 6: dead) at hospitalization discharge, an average of three months
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