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OpenTrials
Completed

NCT Number: NCT02898389

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Pulsatility index on the middle cerebral arteries

    Time frame: Day 0

  2. Diastolic velocity at the middle cerebral arteries

    Time frame: Day 0

  3. Mean velocity at the middle cerebral arteries

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: CritiDop

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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