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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02645851
Eligibility Criteria:
Pre-eligibility criteria:
* Patients presenting on Intensive Care Unit (ICU) admission or later during their ICU stay with arterial hypotension (Mean arterial pressure \[MAP\]\<65mmHg or systolic arterial pressure \[SAP\]\< 90 mmHg at least two times over a 15-minute interval), regardless of the method used to measure blood pressure (invasive or non invasive),
* Or patients already receiving continuous iv vasopressor therapy on ICU admission, regardless of the blood pressure level, will be considered as potential candidates for inclusion in the study, depending on his/her clinical evolution after 6 to 24 hours of care according to current guidelines for shock management.
* In case arterial hypotension is present and/or the patient is already receiving continuous iv vasopressor at ICU admission, the date and time of admission will be considered as the time of shock onset (H0).
* In case arterial hypotension occurs after ICU admission, the date and time of the first episode of hypotension will be considered as the time of shock onset (H0).
Inclusion Criteria:
* Patients will be eligible for inclusion if 6 hours after H0 (and before H24) all the following conditions are present:
* Informed consent obtained (or emergency inclusion possible when legal representatives and patient's family are not present, as allowed by the Ethic Committee and by the French Law)
* Persistence of arterial hypotension (as defined above) or continuous iv infusion of norepinephrine
* Patient under invasive mechanical ventilation
* At least one of the following conditions is present
* Alteration of consciousness
* Mottling skin
* Cyanosis of the extremities despite SaO2\>90%
* Oliguria defined as urine output below 0.5ml/kg of actual body weight over at least 1 hour
* Arterial lactate \> 2 mmol/L
* ScvO2 \< 70%
* Central venous (internal jugular or subclavian) or femoral venous catheter in place
* Arterial catheter in place
Exclusion Criteria:
1. Shock began more than 24 hours ago
2. Age \< 18 yrs.
3. Pregnancy
4. Uncontrolled haemorrhage
5. Intra-aortic balloon counterpulsation in place
6. Patient under veno-arterial extracorporeal membrane oxygenation (V-A ECMO)
7. Cardiogenic pulmonary oedema during the past 24 hours
8. Patient equipped with a cardiac output monitoring device
9. Brain death
10. Moribund patient
11. Traction of a lower limb
12. Amputated lower limb above the ankle level
13. Documented intra-abdominal hypertension
13\. Cardiac arrest motivating ICU admission or cardiac arrest since admission 14. Patient without social security number 15. Consent refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02645851
Study Brief:
Protocol Section:
NCT02645851