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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05707494
Eligibility Criteria:
Inclusion Criteria:
* Weight from 5 kg. up to 40 kg (main criterion),
* Age from 1 month to 14 years,
* No more than 12 hours from the moment of establishment of DZ - Sepsis in accordance with the criteria of SEPSIS-3 (2016, modified for childhood), most likely, Gr-etiology, at the time of inclusion.
* The immediate postoperative period in case of abdominal nature of sepsis (no more than 12 hours after surgery),
* If the patient has a focus of surgical infection, then it should be sanitized,
* pSOFA scale ≥ 6 points, or an increase in negative dynamics on the pSOFA scale by 2 or more points over 12 hours of observation,
* The patient's condition allows for therapy with the Efferon LPS NEO column for at least 4 hours.
Exclusion Criteria:
* Weight below 5 kg and over 40 kg,
* Age less than 1 month and over 14 years old,
* Failure to obtain informed consent from the patient's parents, family member or legal representative,
* The presence of a focus of non-sanitized surgical infection,
* Use in the treatment of other methods of extracorporeal removal of LPS and inflammatory mediators (hemofilters with highly permeable and surface-modified membranes),
* Acute pulmonary embolism,
* Intracranial hemorrhage or bleeding tendency in general,
* Induced aplasia of hematopoiesis,
* If it is impossible to provide vascular access necessary for the method,
* Any other condition that, in the opinion of the Investigator, would prevent the patient from being a suitable candidate for inclusion in the trial (for example, a chronic disease in the terminal stage or a mental disorder that affects the methodology for conducting a hemoperfusion procedure, as well as for patients who have a "palliative status ").
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
14 Years
Study:
NCT05707494
Study Brief:
Protocol Section:
NCT05707494