NCT05057455

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

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

January 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

September 16, 2021

Last Update Submit

September 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • IL-6

    levels of IL-6

    1 YEARS

Study Arms (1)

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

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

ICU patients diagnosed with sepsis or septic shock

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilke Kupeli

Istanbul, 34250, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 34131534BACKGROUND
  • 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.

  • 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.

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 27, 2021

Study Start

January 1, 2020

Primary Completion

December 30, 2020

Study Completion

February 15, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations