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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02079402
Eligibility Criteria:
Inclusion Criteria:
* Adult intensive care patients (age ≥ 18 years) with sepsis defined as 2 of 4 SIRS criteria fulfilled within 24 hours and suspected or confirmed site of infection or positive blood culture.
* Suspected or confirmed circulatory impairment (hypotension/hypoperfusion/hypovolemia) for no more than 12 hours including the hours preceding ICU admission.
* At least 30 ml/kg ideal body weight (IBW) fluid (colloids, crystalloids or blood products) given in the last 6 hours.
* Shock defined as ongoing infusion of norepinephrine (any dose) to maintain blood pressure.
Exclusion Criteria:
* Use of any form of renal replacement therapy (RRT).
* RRT deemed imminent by the ICU doctor, i.e. RRT will be initiated within 6 hours.
* Severe hyperkalemia (p-K \> 6 mM).
* Plasma creatinine \> 350 µmol/l.
* Invasively ventilated with FiO2 \> 0.80 and PEEP \> 10 cmH2O
* Life-threatening bleeding.
* Kidney or liver transplant during current admission.
* Burns \> 10% body surface area (BSA).
* Previously enrolled in the CLASSIC trial and has finished the 90 day observation period.
* Patients for whom it has been decided not to give full life support including mechanical ventilation and RRT.
* Consent not obtainable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02079402
Study Brief:
Protocol Section:
NCT02079402