Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT04290767
Eligibility Criteria:
Inclusion Criteria:
* Septic shock criteria: refractory arterial hypotension or hypoperfusion abnormalities after fluid resuscitation with serum lactate \> 4mmmol/dl, oliguria and mental status alteration or delirium.
* Cardiogenic shock is defined as refractory shock associated with oliguria and mental status alteration following acute myocardial infarction or post-cardiac surgery.
Exclusion Criteria:
* Younger than 18 years old
* Pregnancy
* Diabetes
* Acute or chronic neurological disorder: epileptics, stroke, bleeding, trauma, post-neurosurgery, post- cardiac arrest, tumor, meningitis.
* Severe dementia, psychiatric or neuromuscular disability
* Acute coronary syndrome within one previous week
* Respiratory distress ARDS with arterial oxygenation less than 70mm Hg or the FiO2 / PaO2 ratio \< 200
* Advanced liver cirrhosis
* Terminal renal failure with hemodialysis and high serum uremia.\> 200.
* Drug intoxications. Alcohol withdrawal.
* Advanced malign diseases
* Allergy to the microbubble contrast product Sonovue ®
* Insufficient echogenicity of bilateral temporal window to ultrasound and incomplete insonation of the intracerebral arteries
* Significant intracerebral and extracerebral arteries stenosis or severe atheromatous calcifications.
* Vertebral artery hypoplasia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04290767
Study Brief:
Protocol Section:
NCT04290767