Study of Prognostic Factors in Patients Admitted to ICU for Stroke (REAVC)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Critically Ill

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with acute stroke admitted to ICU in the Brest Teaching Hospital (Cavale Blanche) BREST (The Brest REgistry of STroke)

Description

Inclusion Criteria:

• acute stroke
• ICU admission for acute stroke
• 1 organ dysfunction : coma, shock, respiratory failure

Exclusion Criteria:

• refuse participation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	through ICU hospitalization, an average of one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	At 90 days
Functional outcome: Modified Rankin Score	Modified Rankin Score (0: no symptoms at all; 6: dead)	at hospitalization discharge, an average of three months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): June 29, 2020
• Study Completion (Actual): June 29, 2020

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Stroke; Critical Illness
• Other Study ID Numbers: REAVC ( 29BRC20.0062)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning two year and ending five years following the end study
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No