Status:
COMPLETED
Lipopolysaccharide Adsorption At Septic Shock
Lead Sponsor:
Efferon JSC
Collaborating Sponsors:
Ligand Research, LLC
Conditions:
Septic Shock
Eligibility:
All Genders
18-75 years
Phase:
NA
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
Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). A two-stage trial by Rudnov et al. using one-day data from 62 centres in 29 subjects of the Russian Fed...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Established diagnosis of Gram-negative septic shock according to SEPSIS-3 criteria
- The immediate post-operative period (no more than 24 hours after surgery)
- Hypotension requiring vasopressor support: the need for at least one of the vasopressors listed below at the dose listed below for at least 2 hours continuously and not more than 12 hours.
- Norepinephrine\> 0.05 µg/kg/min
- Dopamine\> 10 µg/kg/min
- Phenylephrine\> 0.4 µg/kg/min
- Adrenaline \> 0.05 µg/kg/min
- Vasopressin\> 0.03 units/min Vasopressin (any dose) in combination with another vasopressor listed above
- The patient must have received intravenous infusion therapy of at least 30 ml/kg administered within 24 hours of inclusion.
- The patient's condition allows therapy with the Efferon LPS device for at least 4 hours.
Exclusion
- Lack of adequate antimicrobial chemotherapy
- Identifying the criteria for non-inclusion;
- A patient may voluntarily withdraw from a trial at any time after giving informed consent and before the trial is completed. The investigator may also withdraw a participant from the trial at any time at his or her discretion and for any of the following reasons:
- Reasons for a participant's withdrawal from the trial will be recorded and may include, amongst others, the following
- Withdrawal of consent to participate in the trial by the participant.
- The development of an adverse event, including a serious one; individual intolerance to the investigational product, hypersensitivity to the components of the product due to which further participation in the trial is not possible.
- Continued participation in the trial is not, in the researcher's opinion, in the participant's health interests.
- The presence of deviations from the plan which, in the opinion of the Sponsor and Investigator, require the withdrawal of the participant from the trial.
- A positive pregnancy test result at any time during the test.
- When any participant withdraws from a trial, the reason for the withdrawal should be documented.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04827407
Start Date
March 23 2021
End Date
August 30 2022
Last Update
September 19 2024
Active Locations (4)
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1
V.P. Demikhov City Clinical Hospital No. 68
Moscow, Russia, 109263
2
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia
3
N.V. Sklifosovsky Moscow Research Institute of Emergency
Moscow, Russia
4
S.S. Yudin City Clinical Hospital
Moscow, Russia