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:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT05369559
Eligibility Criteria:
Inclusion Criteria:
* Patients with spontaneous breathing
* Patients in whom a fluid challenge is indicated because they present acute circulatory failure (which is defined as systolic blood pressure less than 90 mmHg or the need for vasopressors (norepinephrine more than 0.1 µg/kg/min) to maintain a systolic blood pressure more than 90 mmHg (14), and at least one sign of inadequate tissue perfusion:
* urine output of below 0.5ml/kg per hour over 1 hour
* tachycardia (heart rate of greater than 100 beats per minute)
* mottled skin.
* lactate \> 2 mmol/l
Exclusion Criteria:
* Cardiac arrest
* Acute respiratory distress syndrome
* Coma Glasgow Scale \< 14
* Age of less than 18 years
* Moribund patients
* Pregnant patients
* impossibility to perform passive leg raising (PLR) (trauma patients, lower extremity amputees, and prone patients)
* Patients with cardiac arrhythmias
* Patients with cardiogenic pulmonary oedema
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05369559
Study Brief:
Protocol Section:
NCT05369559