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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04947904
Eligibility Criteria:
Inclusion Criteria:
* Patient suffering from an infection already documented or suspected
* Patient with organ dysfunction defined as an acute change in SOFA score ≥ 2 points
* Patient with refractory hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mm Hg in spite of resuscitation with an adequate volume of intravenous fluids (according to the recommendations of the Surviving Sepsis campaign). The treatment by vasopressor must have been started less than 24 hours before inclusion and randomization.
* Patient with hyperlactatemia (blood lactate \> 2 mmol / L). This criterion must be fulfilled at least once for the purpose of the diagnosis within the 24 hours preceding inclusion and randomization.
* Patient or close relative / legal representative / family member / curator / tutor must have given written informed consent and signed the consent form for the patient included in an emergency situation
* Patient must be covered by a health insurance scheme.
* Adult patient (≥18 years) under 85 years old (\< 85).
Exclusion Criteria:
* Patient who has had a previous episode of septic shock requiring vasopressor administration or mechanical ventilation or renal replacement therapy during the current ICU stay.
* A patient whose life expectancy is shortened due to his/her initial health condition or a moribund patient whose life expectancy is less than 48 hours or whose decision to limit comprehensive care was made before including the patient.
* Patient who has had a recent cardiac arrest (during current hospital stay)
* Patient requiring emergency renal-replacement therapy (hyperkalemia \[potassium \> 6.5 mmol/l\] refractory to medical treatment and/or metabolic acidosis \[pH \<7.15 and partial pressure of carbon dioxide (pCO2) \<45 mmHg\] refractory to medical treatment and/or pulmonary edema in anuric patients who do not respond to diuretic therapy).
* Patient with KDIGO 3 acute kidney injury and likely to require renal-replacement therapy within the next 24 hours, as determined by the patient's clinician in charge
* Patients with end-stage chronic renal failure or patients already undergoing chronic dialysis
* Severely malnourished patient in whom nutritional support is an emergency procedure (body mass index \<18 kg / m2)
* Patient participating in or having participated in an interventional study with similar patient outcome in the previous 3 months.
* Patient in an exclusion period determined by another study.
* Patient under legal protection.
* Pregnant patient (positive serum pregnancy test).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04947904
Study Brief:
Protocol Section:
NCT04947904