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Lipopolisaccharide Adsorption at Septic Shock (LASSO)

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Efferon LPS hemoperfusion
Sponsored by
Efferon JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, extracorporeal therapy, LPS adsorption, abdominal sepsis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

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.

Sites / Locations

  • V.P. Demikhov City Clinical Hospital No. 68
  • N.I. Pirogov City Clinical Hospital No. 1
  • N.V. Sklifosovsky Moscow Research Institute of Emergency
  • S.S. Yudin City Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Basic therapy + Efferon LPS

Baseline therapy

Arm Description

Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS)

Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis.

Outcomes

Primary Outcome Measures

Effect of the Efferon LPS hemoperfusion in extracorporeal therapy in patients with abdominal sepsis complicated by septic shock
The time (number of days) from randomisation to the earliest time that the 'resolution of septic shock' event is achieved. Event criteria: 1) end of vasopressor support (persistence of effect - for 4 hours) and 2) investigator/trained staff rating the trial as 'resolved' when assessed from baseline to day 14 or hospital discharge (if discharge occurs earlier than day 14).

Secondary Outcome Measures

Effect of the Efferon LPS hemoperfusion on systemic haemodynamic parameters after the start of use in patients with abdominal sepsis complicated by septic shock
Sats every 6 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours. The time (number of days) from randomisation to the end of vasopressor support within 72 x hours or hospital discharge (if earlier than 72 hours). Maximum dose of vasopressors within 24 hours and 72 hours of the start of hemoperfusion.
Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function in patients with abdominal sepsis complicated by septic shock
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours
Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU of patients with abdominal sepsis complicated by septic shock
The time (number of days) from randomisation to transfer from the ORIT within 14 days or hospital discharge or transfer from the ORIT (if occurring earlier than day 14).

Full Information

First Posted
March 30, 2021
Last Updated
January 12, 2023
Sponsor
Efferon JSC
Collaborators
Ligand Research, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04827407
Brief Title
Lipopolisaccharide Adsorption at Septic Shock
Acronym
LASSO
Official Title
Lipopolisaccharide Adsorption at Septic Shock With Efferon LPS Extracorporeal Blood Adsorbers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Efferon JSC
Collaborators
Ligand Research, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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\or excess of cytokines improve treatment outcomes in patients with septic shock. The main purpose of the study is to obtain new data on the efficacy and safety of the Efferon LPS device in extracorporeal therapy in patients with abdominal sepsis complicated by septic shock.
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 Federation showed that one third of the patients admitted to the ICU were patients with infection, one fifth of them developed septic shock, the proportion of hospital sepsis was 46.6%, and fatal outcome occurred in 30.4% of patients with infection. Despite apparent advances in intensive care, the prognosis of patients with endotoxaemia and septic shock remains poor. Extracorporeal removal of toxic substances from the bloodstream by adsorbing them onto a porous material may provide clear clinical benefits. Extracorporeal blood adsorption method can be a good complement or substitute for the classical methods of haemofiltration and haemodialysis if the diffusion or convection of toxic substances through the membrane is not efficient enough. Since the method was first proposed by Muirhead and Reid in 1948, it has developed considerably. Endotoxin (lipopolysaccharide), one of the most potent mediators of sepsis, is found in high concentrations in about 50% of patients with septic shock. The use of extracorporeal sorption techniques that eliminate endotoxin has been shown in numerous trials to improve outcomes in patients with septic shock. Efferon LPS (Efferon JSC, Moscow, Russia) is a single-use therapeutic device for extracorporeal blood purification using direct hemoperfusion. Detoxification is carried out by selective adsorption of lipopolysaccharides (bacterial endotoxins) and non-selective removal of cytokines by internal porous structure. It is a cylindrical polycarbonate casing filled with spherical granules of LPS-selective polymeric adsorbent mesoporous beads and isotonic sodium chloride solution. The device is registered in Russia as a medical device RZN 2019/8886.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, extracorporeal therapy, LPS adsorption, abdominal sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicentre randomised clinical trial evaluating the efficacy and safety of the Efferon LPS device in extracorporeal hemoperfusion in patients with abdominal sepsis complicated with septic shock.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic therapy + Efferon LPS
Arm Type
Experimental
Arm Description
Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS)
Arm Title
Baseline therapy
Arm Type
No Intervention
Arm Description
Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis.
Intervention Type
Device
Intervention Name(s)
Efferon LPS hemoperfusion
Other Intervention Name(s)
extracorporeal blood adsorption
Intervention Description
Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 24h immediately following admission to the intensive care unit
Primary Outcome Measure Information:
Title
Effect of the Efferon LPS hemoperfusion in extracorporeal therapy in patients with abdominal sepsis complicated by septic shock
Description
The time (number of days) from randomisation to the earliest time that the 'resolution of septic shock' event is achieved. Event criteria: 1) end of vasopressor support (persistence of effect - for 4 hours) and 2) investigator/trained staff rating the trial as 'resolved' when assessed from baseline to day 14 or hospital discharge (if discharge occurs earlier than day 14).
Time Frame
1-14 days
Secondary Outcome Measure Information:
Title
Effect of the Efferon LPS hemoperfusion on systemic haemodynamic parameters after the start of use in patients with abdominal sepsis complicated by septic shock
Description
Sats every 6 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours. The time (number of days) from randomisation to the end of vasopressor support within 72 x hours or hospital discharge (if earlier than 72 hours). Maximum dose of vasopressors within 24 hours and 72 hours of the start of hemoperfusion.
Time Frame
1-72 hours
Title
Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function in patients with abdominal sepsis complicated by septic shock
Description
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours
Time Frame
1-72 hours
Title
Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU of patients with abdominal sepsis complicated by septic shock
Description
The time (number of days) from randomisation to transfer from the ORIT within 14 days or hospital discharge or transfer from the ORIT (if occurring earlier than day 14).
Time Frame
1-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Rey, MD, PhD
Organizational Affiliation
N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vladimir Kulabukhov, MD, PhD
Organizational Affiliation
N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
V.P. Demikhov City Clinical Hospital No. 68
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
Facility Name
N.I. Pirogov City Clinical Hospital No. 1
City
Moscow
Country
Russian Federation
Facility Name
N.V. Sklifosovsky Moscow Research Institute of Emergency
City
Moscow
Country
Russian Federation
Facility Name
S.S. Yudin City Clinical Hospital
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Ushakova N.D., Tikhonova S.N., Rozenko D.A. Hemosorption by a Column Adsorber Based on Hyper-Cross-Linked Styrene-Divinylbenzene Copolymer with Immobilized Lipopolysaccharide-Selective Ligand in Combined Intensive Care of Lung Cancer-Related Postoperative Acute Lung Injury (Case Report). General Reanimatology. 2020;16(4):14-20. https://doi.org/10.15360/1813-9779-2020-4-14-20
Results Reference
background
Citation
Magomedov M.A., Kim T.G., Masolitin S.V., Yaralian A.V., Kalinin E.Yu., Pisarev V.M. Use of Sorbent Based on Hypercrosslinked Styrene-Divinylbenzene Copolymer With Immobilized LPS-Selective Ligand In Hemoperfusion For Treatment of Patients With Septic Shock. General Reanimatology. 2020;16(6):31-53. https://doi.org/10.15360/1813-9779-2020-6-31-53
Results Reference
background
Links:
URL
https://doi.org/10.15360/1813-9779-2020-4-14-20
Description
https://doi.org/10.15360/1813-9779-2020-4-14-20
URL
https://doi.org/10.15360/1813-9779-2020-6-31-53
Description
https://doi.org/10.15360/1813-9779-2020-6-31-53

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Lipopolisaccharide Adsorption at Septic Shock

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