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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03818269
Eligibility Criteria:
Inclusion Criteria:
Criteria common to both groups:
* Adult,
* Admitted within the last 24 hours in intensive care,
* Under mechanical ventilation with orotracheal intubation,
* Without clinically detectable edema (in any area)
* Patient and/or guardian and/or close relative has given written consent
Patients included in the "septic shock" arm:
* Diagnosis of septic shock as defined by the "Sepsis-3" Consensus Conference (JAMA 2016) (34): documented or highly suspected infection with SOFA ≥ 2, persistent hypotension after correction of hypovolemia requiring vasopressor administration, and serum lactate \> 2 mmol/l.
* Vascular filling \< 50 ml/kg
Patients included in the control arm:
* Absence of sepsis and shock from any cause:
* PAS \> 100 mmHg
* Absence of vasopressors
* Preserved urine \> 0.5 ml/kg/h
* Normal serum lactate
* Crystalloid infusions \< 50ml/kg over the previous 12 hours
Exclusion Criteria:
* not affiliated to national health insurance
* under court protection
* pregnant or breastfeeding
* Clinical disseminated intravascular coagulation (DIC) with hemorrhagic syndrome
* Admitted after resuscitation for cardiac arrest
* Presenting cardiogenic shock
* Presenting acute pancreatitis
* Severe overall dehydration (clinical signs of dehydration and natremia \> 150mmol/l)
* Presenting metformin intoxication
* In severe sepsis or septic shock for more than 24 hours,
* Dying or for whom death seems imminent (within 24 hours),
* Hypersensitivity to lidocaine and/or prilocaine or local anesthetics of the amide type or to any of the excipients of EMLAPATCH®
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03818269
Study Brief:
Protocol Section:
NCT03818269