NCT04884854

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. Aim of the study: to evaluate safety and feasibility of clinical use of an extracorporeal blood adsorber based on a hypercrosslinked styrene-divinylbenzene copolymer with immobilized lipopolysaccharide (LPS)-selective ligand designed to remove endotoxins from the bloodstream to treat patients with septic shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

April 26, 2021

Last Update Submit

May 31, 2021

Conditions

Septic Shock

Keywords

septic shockextracorporeal therapyLPS sequestrationabdominal sepsis

Outcome Measures

Primary Outcomes (1)

  • Effect of Efferon LPS hemoperfusion on vasopressor dose after initiation of use in patients with abdominal sepsis complicated by septic shock.

    The time (number of hours) from inclusion in the study to the earliest time that the 'resolution of septic shock' event is achieved. Event criteria is end of vasopressor support (persistence of effect - for 4 hours).

    1-120 hours

Secondary Outcomes (5)

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

    1-120 hours

  • Effect of LPS Efferon hemoperfusion on SOFA scores in patients with abdominal sepsis complicated by septic shock.

    1-120 hours

  • Effect of LPS Efferon hemoperfusion on procalcitonin levels in patients with abdominal sepsis complicated by septic shock.

    1-120 hours

  • Effect of LPS Efferon hemoperfusion on endotoxin activity in patients with abdominal sepsis complicated by septic shock.

    1-72 hours

  • Effect of LPS Efferon hemoperfusion on IL-1β levels in patients with abdominal sepsis complicated by septic shock.

    1-24 hours

Interventions

Efferon LPSDEVICE

Efferon LPS 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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included 9 surgical patients with clinical signs of septic shock (SEPSIS-3, 2016) who were admitted to the intensive care unit (ICU) in 2019-2020.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.I. Pirogov City Clinical Hospital No. 1

Moscow, 119049, Russia

Location

Related Publications (13)

  • Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288.

    PMID: 26903335RESULT

  • Besen BAMP, Romano TG, Nassar AP Jr, Taniguchi LU, Azevedo LCP, Mendes PV, Zampieri FG, Park M. Sepsis-3 definitions predict ICU mortality in a low-middle-income country. Ann Intensive Care. 2016 Dec;6(1):107. doi: 10.1186/s13613-016-0204-y. Epub 2016 Nov 2.

    PMID: 27807819RESULT

  • Hurley JC. The Role of Endotoxin in Septic Shock. JAMA. 2019 Mar 5;321(9):902-903. doi: 10.1001/jama.2018.20874. No abstract available.

    PMID: 30835303RESULT

  • Shoji H, Tani T, Hanasawa K, Kodama M. Extracorporeal endotoxin removal by polymyxin B immobilized fiber cartridge: designing and antiendotoxin efficacy in the clinical application. Ther Apher. 1998 Feb;2(1):3-12. doi: 10.1111/j.1744-9987.1998.tb00066.x.

    PMID: 10227782RESULT

  • Zhou F, Peng Z, Murugan R, Kellum JA. Blood purification and mortality in sepsis: a meta-analysis of randomized trials. Crit Care Med. 2013 Sep;41(9):2209-20. doi: 10.1097/CCM.0b013e31828cf412.

    PMID: 23860248RESULT

  • Cruz DN, Perazella MA, Bellomo R, de Cal M, Polanco N, Corradi V, Lentini P, Nalesso F, Ueno T, Ranieri VM, Ronco C. Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care. 2007;11(2):R47. doi: 10.1186/cc5780.

    PMID: 17448226RESULT

  • Esteban E, Ferrer R, Alsina L, Artigas A. Immunomodulation in sepsis: the role of endotoxin removal by polymyxin B-immobilized cartridge. Mediators Inflamm. 2013;2013:507539. doi: 10.1155/2013/507539. Epub 2013 Oct 22.

    PMID: 24249974RESULT

  • Yaroustovsky M, Abramyan M, Krotenko N, Popov D, Plyushch M, Rogalskaya E, Nazarova H. Combined extracorporeal therapy for severe sepsis in patients after cardiac surgery. Blood Purif. 2014;37(1):39-46. doi: 10.1159/000357015. Epub 2014 Feb 5.

    PMID: 24503765RESULT

  • Yaroustovsky M, Abramyan M, Popok Z, Nazarova E, Stupchenko O, Popov D, Plushch M, Samsonova N. Preliminary report regarding the use of selective sorbents in complex cardiac surgery patients with extensive sepsis and prolonged intensive care stay. Blood Purif. 2009;28(3):227-33. doi: 10.1159/000231988. Epub 2009 Aug 14.

    PMID: 19684388RESULT

  • Martin EL, Cruz DN, Monti G, Casella G, Vesconi S, Ranieri VM, Ronco C, Antonelli M. Endotoxin removal: how far from the evidence? The EUPHAS 2 Project. Contrib Nephrol. 2010;167:119-125. doi: 10.1159/000315926. Epub 2010 Jun 1.

    PMID: 20519906RESULT

  • Iba T, Klein DJ. The wind changed direction and the big river still flows: from EUPHRATES to TIGRIS. J Intensive Care. 2019 May 16;7:31. doi: 10.1186/s40560-019-0386-0. eCollection 2019.

    PMID: 31131109RESULT

  • Yin C, Liu W, Liu Z, Huang Y, Ci L, Zhao R, Yang X. Identification of potential serum biomarkers in pigs at early stage after Lipopolysaccharide injection. Res Vet Sci. 2017 Apr;111:140-146. doi: 10.1016/j.rvsc.2017.02.016. Epub 2017 Feb 17.

    PMID: 28249176RESULT

  • Kogelmann K, Jarczak D, Scheller M, Druner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. doi: 10.1186/s13054-017-1662-9.

    PMID: 28343448RESULT

MeSH Terms

Conditions

Shock, SepticIntraabdominal Infections

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Timur Kim, MD

    N.I. Pirogov Clinical City Hospital No. 1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 13, 2021

Study Start

September 13, 2019

Primary Completion

March 20, 2020

Study Completion

October 12, 2020

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)