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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT02898389

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Respiration, Artificial Sedated

Study Design

Study Type:

Observational

Actual Enrollment :

91 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 14, 2016

Actual Primary Completion Date :

Sep 14, 2018

Actual Study Completion Date :

Sep 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

Pulsatility index on the middle cerebral arteries [Day 0]
Diastolic velocity at the middle cerebral arteries [Day 0]
Mean velocity at the middle cerebral arteries [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for entry in the study:

Sedated patient under mechanical respiratory assistance

Inclusion criteria for entry in group 1: the patient meets at least one of the following criteria:

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

Inclusion criteria for entry in group 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09		France	30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Laurent Muller, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT02898389

Other Study ID Numbers:

LOCAL/2015/LM-01b
NCT03043092

First Posted:

Sep 13, 2016

Last Update Posted:

Aug 12, 2020

Last Verified:

Aug 1, 2020

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Aug 12, 2020