Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients

NCT ID: NCT02898389

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-14

Study Completion Date

2018-09-14

Brief Summary

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The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.

Detailed Description

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Conditions

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Respiration, Artificial Sedated

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: With cardiovascular risk factors

Patients fall within this group when they have at least one of the cardiovascular risk factors listed in the eligibility criteria section.

No interventions assigned to this group

Group 1: Without cardiovascular risk factors

Patients fall into this group when they do not have any of the cardiovascular risk factors listed in the eligibility criteria section.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Sedated patient under mechanical respiratory assistance


* The patient is a man over the age of 50 or a woman over the age of 60
* Hypercholesterolemia (LDL \> 1.6 g/L, HDL \< 0.4 g/L)
* Arterial hypertension for over 10 years (treated or systolic arterial pressure \> 140 mmHG)
* Type 2 diabetes for over 10 years
* Active or former smoker in the past 3 years
* History of cardiovascular event (peripheral artery disease, heart attack, stroke/transient ischemic attack over 3 months ago)
* Chronic renal insufficiency with MDRD \< 30 ml/min/1.73m\^2


* The included patient is not in group 1

Exclusion Criteria

* acute neurological disorder (brain trauma, infectious or immune meningitis, meningoencephalitis, ischemic or hemorrhagic stroke \<3 months)
* pregnant woman
* person under guardianship
* prisoners
* recent carotid surgery (\<1 month)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Muller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2015/LM-01b

Identifier Type: -

Identifier Source: org_study_id

NCT03043092

Identifier Type: -

Identifier Source: nct_alias

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