Trial reportCritical care (London, England)2011
Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study.
Trial report in Critical care (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00818597 (PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Granulocyte transfusions for treating infections in people with neutropenia or neutrophil dysfunction.The Cochrane database of systematic reviews · 2016Pooled it
- Granulocyte transfusions for preventing infections in people with neutropenia or neutrophil dysfunction.The Cochrane database of systematic reviews · 2015Pooled it
- Bioartificial Therapy of Sepsis: Changes of Norepinephrine-Dosage in Patients and Influence on Dynamic and Cell Based Liver Tests during Extracorporeal Treatments.BioMed research international · 2016Trial
- Purified Granulocyte Concentrates from Buffy Coats with Extended Storage Time.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2024Article
- Extracorporeal immune cell therapy of sepsis: ex vivo results.Intensive care medicine experimental · 2022Article
- CXCL5-mediated recruitment of neutrophils into the peritoneal cavity ofProceedings of the National Academy of Sciences of the United States of America · 2020Article
- Endothelial bioreactor system ameliorates multiple organ dysfunction in septic rats.Intensive care medicine experimental · 2016Article
- Broad spectrum immunomodulation using biomimetic blood cell margination for sepsis therapy.Lab on a chip · 2016Article
- Sepsis-induced immunosuppression: from cellular dysfunctions to immunotherapy.Nature reviews. Immunology · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNeutrophil granulocytes are the first defense line in bacterial infections. However, granulocytes are also responsible for severe local tissue impairment. In order to use donor granulocytes, but at the same time to avoid local side effects, we developed an extracorporeal immune support system. This first-in-man study investigated whether an extracorporeal plasma treatment with a granulocyte bioreactor is tolerable in patients with septic shock. A further intention was to find suitable efficacy end-points for subsequent controlled trials.
methodsThe trial was conducted as a prospective uncontrolled clinical phase I/II study with 28-day follow-up at three university hospital intensive care units. Ten consecutive patients (five men, five women, mean age 60.3 ± 13.9 standard deviation (SD) years) with septic shock with mean ICU entrance scores of Acute Physiology and Chronic Health Evaluation (APACHE) II of 29.9 ± 7.2 and of Simplified Acute Physiology Score (SAPS) II of 66.2 ± 19.5 were treated twice within 72 hours for a mean of 342 ± 64 minutes/treatment with an extracorporeal bioreactor containing 1.41 ± 0.43 × 10E10 granulocytes from healthy donors. On average, 9.8 ± 2.3 liters separated plasma were treated by the therapeutic donor cells. Patients were followed up for 28 days.
resultsTolerance and technical safety during treatment, single organ functions pre/post treatment, and hospital survival were monitored. The extracorporeal treatments were well tolerated. During the treatments, the bacterial endotoxin concentration showed significant reduction. Furthermore, noradrenaline dosage could be significantly reduced while mean arterial pressure was stable. Also, C-reactive protein, procalcitonin, and human leukocyte antigen DR (HLA-DR) showed significant improvement. Four patients died in the hospital on days 6, 9, 18 and 40. Six patients could be discharged.
conclusionsThe extracorporeal treatment with donor granulocytes appeared to be well tolerated and showed promising efficacy results, encouraging further studies.
trial registrationClinicalTrials.gov Identifier: NCT00818597.
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