Lipopolysaccharide Adsorption At Septic Shock

NCT04827407 | Completed DMC

• 1 other identifier: efferon-lps-2021-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Septic Shock

Keywords

septic shock; extracorporeal therapy; LPS adsorption; abdominal sepsis

Outcome Measures

Primary Outcomes (1)

• 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).

  1-14 days

Secondary Outcomes (3)

• Effect of the Efferon LPS hemoperfusion on systemic haemodynamic parameters after the start of use in patients with abdominal sepsis complicated by septic shock

  1-72 hours

• Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function in patients with abdominal sepsis complicated by septic shock

  1-72 hours

• Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU of patients with abdominal sepsis complicated by septic shock

  1-14 days

Study Arms (2)

Basic therapy + Efferon LPS

EXPERIMENTAL

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)

Device: Efferon LPS hemoperfusion

Baseline therapy

NO INTERVENTION

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

Interventions

Efferon LPS hemoperfusion DEVICE

Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 24h immediately following admission to the intensive care unit

Also known as: extracorporeal blood adsorption

Basic therapy + Efferon LPS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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's condition allows therapy with the Efferon LPS device for at least 4 hours.

You may not qualify if:

• Lack of adequate antimicrobial chemotherapy
• 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.

Sponsors & Collaborators

• Efferon JSC: lead
• Ligand Research, LLC: collaborator

Study Sites (4)

V.P. Demikhov City Clinical Hospital No. 68

Moscow, 109263, Russia

Location

N.I. Pirogov City Clinical Hospital No. 1

Moscow, Russia

Location

N.V. Sklifosovsky Moscow Research Institute of Emergency

Moscow, Russia

Location

S.S. Yudin City Clinical Hospital

Moscow, Russia

Location

Related Publications (3)

• Rey S, Kulabukhov VM, Popov A, Nikitina O, Berdnikov G, Magomedov M, Kim T, Masolitin S, Ignatenko O, Krotenko N, Marysheva A, Chaus N, Ohinko L, Mendibaev M, Chumachenko A, Pisarev V. HEMOPERFUSION USING THE LPS-SELECTIVE MESOPOROUS POLYMERIC ADSORBENT IN SEPTIC SHOCK: A MULTICENTER RANDOMIZED CLINICAL TRIAL. Shock. 2023 Jun 1;59(6):846-854. doi: 10.1097/SHK.0000000000002121. Epub 2023 Apr 6.

  PMID: 37018802 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Related Links

• https://doi.org/10.15360/1813-9779-2020-4-14-20
• https://doi.org/10.15360/1813-9779-2020-6-31-53
• https://doi.org/10.21320/1818-474X-2023-4-60-71

MeSH Terms

Conditions

Shock, Septic; Intraabdominal Infections

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sergey Rey, MD, PhD

  N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia

  PRINCIPAL INVESTIGATOR

• Vladimir Kulabukhov, MD, PhD

  N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 23, 2021
• Primary Completion: March 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)