Evidence map›Paper›PMID 35620768›Full record

ArticleCritical care explorations2022

Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.

Lenar T Yessayan, Javier A Neyra, Angela J Westover, Balazs Szamosfalvi, H David Humes

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Critical care explorations, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05758077 (A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05758077 narecruitingnot on this mapstarted 2023, after this paper: background citation

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy

TypeinterventionalSponsorSeaStar MedicalRan2023 to 2027Enrolled339ConditionsAcute Kidney InjuryArmsSelective Cytopheretic Device, Standard of Care
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Lenar T YessayanDepartment of Internal Medicine (Nephrology), University of Michigan, Ann Arbor, MI.
Javier A NeyraDepartment of Internal Medicine (Nephrology, Bone and Mineral Metabolism), University of Kentucky, Lexington, KY.
Angela J WestoverDepartment of Internal Medicine (Nephrology), University of Michigan, Ann Arbor, MI.
Balazs SzamosfalviDepartment of Internal Medicine (Nephrology), University of Michigan, Ann Arbor, MI.
H David HumesDepartment of Internal Medicine (Nephrology), University of Michigan, Ann Arbor, MI.
University of Michigan · USUniversity of Kentucky · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To evaluate safety and clinical outcomes of extracorporeal immunomodulation treatment with a selective cytopheretic device (SCD) in COVID-19 ICU patients with multiple organ failure.

designTwo-center, prospective, single-arm treatment clinical trial.

settingICUs at two academic medical centers between September 2020 and July 2021. PATIENTS: Twenty-two COVID-10 patients in the ICU with acute respiratory distress syndrome who required mechanical ventilation. Nearly all included patients in the intervention group except one had acute kidney injury requiring continuous renal replacement therapy (CRRT). Sixteen subjects meeting enrollment criteria were selected as contemporaneous controls from a concurrent prospective registry CRRT trial.

interventionTreatment with an SCD integrated into a continuous renal replacement extracorporeal blood circuit for up to 10 days to provide autologous leukocyte cell processing to immunomodulate the hyperinflammatory disease state of COVID-19. MEASUREMENTS AND MAIN

resultsSCD treatment in COVID-19 ICU patients with multiple organ failure demonstrated an acceptable safety profile with no device-related serious adverse events. Treatment of these patients resulted in the selective removal of highly activated circulating leukocytes as determined by flow cytometry. Significant reductions were observed in the elevated plasma levels of eight cytokines and biomarkers, including interleukin (IL)6, IL15, IL10, and soluble ST2, which are predictive of mortality in COVID-19 patients. Significant improvements of leukocytosis and Po

conclusionsExtracorporeal immunomodulation therapy with an SCD demonstrated safety without any device-related serious adverse events. As a rescue therapy in COVID-19 ICU patients progressing to multiple organ failure despite maximal pharmacologic and organ support interventions, SCD treatment resulted in improved clinical outcomes. This autologous leukocyte cell processing technology may provide a new approach in the treatment of unremitting hyperinflammation of COVID-19.

Indexed as

acute kidney injuryacute respiratory distress syndromeCOVID-19extracorporeal therapyimmunomodulationintensive care unit

Identifiers

PMID35620768
PMCPMC9126516
OpenAlexW4281286342

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.