Cytokine Hemadsorption in Covid 19 Patients With Bacterial Sepsis
Sponsor
Derince Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04920851
Collaborator
(none)
23
1
1.3
17.5
Study Details
Study Description
Brief Summary
In this retrospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
23 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Cytokine Hemadsorption as an Immunomodulator Therapy in Covid 19 Patients With and Without Bacterial Sepsis
Anticipated Study Start Date
:
Jun 10, 2021
Anticipated Primary Completion Date
:
Jul 5, 2021
Anticipated Study Completion Date
:
Jul 20, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Covid with sepsis Covid patient with sepsis |
Device: cytokine hemadsorption
to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
|
| covid without sepsis Covid patient without sepsis |
Device: cytokine hemadsorption
to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
|
Outcome Measures
Primary Outcome Measures
- interleukin 6 [1 month]
level of interleukin 6
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test),
-
patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture
Exclusion Criteria:
-
below 18 aged
-
those who did not undergo hemoperfusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Biruni University | Istanbul | Küçükçekmece | Turkey | 34100 |
Sponsors and Collaborators
- Derince Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.
Responsible Party:
İLKE KÜPELİ,
ASSOC. PROF,
Biruni University
ClinicalTrials.gov Identifier:
NCT04920851
Other Study ID Numbers:
- BIRUNI 1
First Posted:
Jun 10, 2021
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: