Effectiveness of the Cytokine Hemadsorption on Sepsis

Interleukin-6 Clinical Trial

Official title:

Effectiveness of the Cytokine Hemadsorption on the Clinical Progression and Mortality of Intensive Care Patients With Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057455
• Other study ID #: BIRUNI 2
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: September 2021
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 15, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Interleukin-6
• Sepsis

Intervention

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

Locations

Country	Name	City	State
Turkey	Ilke Kupeli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bahar I, Oksuz H, Senoglu N, Demirkiran H, Aydogan M, Tomak Y, Çömez M, Bayrakçi S, Gönüllü 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. — View Citation

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. Review. — View Citation

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 2 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6	levels of IL-6	1 YEARS