Status:
COMPLETED
Efferon LPS Hemoperfusion for Treatment of Patients With Septic Shock
Lead Sponsor:
Efferon JSC
Conditions:
Septic Shock
Eligibility:
All Genders
18-80 years
Brief Summary
Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). Numerous studies have shown that extracorporeal hemoperfusion therapies that eliminate endotoxin and\\o...
Detailed Description
Introduction. Sepsis, according to the latest consensus definition (SEPSIS-3, 2016), is a disease characterized by life-threatening organ failure resulting from a disordered regulation of the body's re...
Eligibility Criteria
Inclusion
- Gram-negative agents in the blood; or detection of an infection focus suggesting Gram-negative agents; or suspected infection based on patient condition, presence of at least two criteria for a systemic inflammatory response and procalcitonin (PCT) level ≥ 2 ng/ml;
- severity of organ dysfunction assessed on a Sepsis-related Organ Failure Assessment (SOFA) scale \> 4 points as a result of an evident or suspected infection;
- need for vasopressor support after administration of fluids to maintain an average blood pressure of at least 65 mmHg. and lactate level in serum \> 2 mmol/l (optional, for diagnosis of septic shock).
- An additional criterion was the endotoxin activity exceeding 0.6 units according to EAA
Exclusion
- terminal condition,
- ongoing internal bleeding or high risk of bleeding,
- severe heart failure (left ventricular ejection fraction \< 25%),
- decompensated liver failure,
- body weight less than 20 kg,
- age \< 18 or \> 80 years.
Key Trial Info
Start Date :
September 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 12 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04884854
Start Date
September 13 2019
End Date
October 12 2020
Last Update
June 3 2021
Active Locations (1)
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1
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia, 119049