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CompletedNCT05057455Updated Sep 27, 2021

Effectiveness of the Cytokine Hemadsorption on Sepsis

An observational study in Interleukin-6, sponsored by Biruni University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by Biruni University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
18 Years to 100 Years
Sex
All
01

Study summary

In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.

02

Conditions studied

  • Interleukin-6

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03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 39 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Biruni University is the lead sponsor of 172 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In this one-centered study, we prospectively analyzed the outcomes and laboratory findings of 39 patients diagnosed with sepsis from 01 Jan 2020 to 30 December 2020 hospitalized in ICU.

Inclusion criteria

  • the patients were the available data of clinical and laboratory diagnosis of sepsis and septic shock
  • detection of gram-negative bacterial agent in blood or sputum culture.
  • patients who had the shock symptoms such as hypotension, tachycardia or fever during the course of sepsis.

Exclusion criteria

Exclusion Criteria:

  • had uncontrolled hemorrhage,
  • diagnosed with cardiac failure at stage 4 or renal failure at stage 4 or hepatic liver failure at stage 4
  • cancer at the end stage or admitted with acute coronary syndrome.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU patients diagnosed with sepsis or septic shock

    compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.

    Procedure: cytokine hemadsorption

Interventions

  • Procedurecytokine hemadsorption

    the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.

06

What researchers measure

Primary outcomes

  1. IL-6

    levels of IL-6

    Time frame: 1 YEARS

07

Study locations

1 site
  • Ilke Kupeli
    Istanbul, 34250, Turkey
08

References and documents

Publications

  • Bahar I, Oksuz H, Senoglu N, Demirkiran H, Aydogan M, Tomak Y, Comez M, Bayrakci S, Gonullu E, Berktas M. Compliance With the Surviving Sepsis Campaign Bundle: A Multicenter Study From Turkey. Cureus. 2021 May 12;13(5):e14989. doi: 10.7759/cureus.14989. PubMed 34131534 ↗
  • Houschyar KS, Pyles MN, Rein S, Nietzschmann I, Duscher D, Maan ZN, Weissenberg K, Philipps HM, Strauss C, Reichelt B, Siemers F. Continuous hemoadsorption with a cytokine adsorber during sepsis - a review of the literature. Int J Artif Organs. 2017 May 29;40(5):205-211. doi: 10.5301/ijao.5000591. Epub 2017 May 19. PubMed 28525674 ↗
  • Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10. PubMed 32283152 ↗
  • Bonavia A, Groff A, Karamchandani K, Singbartl K. Clinical Utility of Extracorporeal Cytokine Hemoadsorption Therapy: A Literature Review. Blood Purif. 2018;46(4):337-349. doi: 10.1159/000492379. Epub 2018 Sep 3. PubMed 30176653 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05057455
Lead sponsor
Biruni University
Responsible party
IKUPELI (investigator, Biruni University) — Principal investigator
First posted
Sep 27, 2021
Start date
Jan 1, 2020
Primary completion
Dec 30, 2020
Completion
Feb 15, 2021
Last update
Sep 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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