An interventional study of CytoSorb cytokine elimination in Inflammation, sponsored by Universitätsklinikum Hamburg-Eppendorf. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
This study evaluates the effect of extracorporeal removal of inflammatory mediators on the systemic inflammation reaction of patients admitted to the intensive care unit following elective esophagectomy. Half of the participants will be treated with an adsorption device (CytoSorbents Adsorber), while the other half will be treated according to standard care. Significant reductions of interleukin-6 plasma concentration, SOFA score and catecholamine dosage in the intervention group are expected.
Radical esophagectomy combined with extensive lymphadenectomy for esophageal cancer is one of the most invasive surgical procedures. Even with progress made in surgical technique and postoperative management the rate of short- and long term complications remains high. The surgical trauma invariably causes liberation and activation of inflammatory mediators and danger associated molecular patterns, which in turn result in a pronounced systemic inflammatory reaction, leading to multiorgan dysfunction including adult respiratory distress syndrome (ARDS) in many patients. The subsequent counter regulation of the immune system induces immune paralysis, which is followed by infectious complications and increases the probability of severe sepsis. Moreover, severe systemic inflammation causes capillary leakage, resulting in impaired wound healing and endangered anastomoses.
Therefore, it seems that early and effective measures against the excessive production of mediators and cytokines are indicated without impairment of the innate and adaptive immune response as it would be expected with the administration of e.g. steroids. Instead, the removal of an excessive amount of circulating cytokines might be a desirable method having shown its effectivity in the therapy of septic shock in the past.
The aim of this study is to demonstrate the effectiveness of extracorporeal cytokine removal to dampen the systemic inflammatory response following abdominal-thoracic esophagectomy.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
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Exclusion Criteria:
intensive care therapy according to international standards and following local SOPs, including fluid therapy, mechanical ventilation, catecholamine therapy and other pharmacotherapy as required
all of the above, plus extracorporeal hemadsorption therapy (CytoSorbents Adsorber cartridge) using continuous veno-venous hemofiltration (citrate anticoagulation) CytoSorb cytokine elimination
Device: CytoSorb cytokine elimination
Hemoperfusion using continuous veno-venous hemofiltration (citrate regional anticoagulation) with CytoSorb cytokine elimination over a period of 48h immediately following admission to the intensive care unit
Also known as: hemadsorption
Change of interleukin-6 plasma levels
Change of interleukin-6 plasma levels
Time frame: 72 hours
Change in SOFA Score
decrease of \>= 2 score points in the intervention group
Time frame: 120 hours
Change of catecholamine dose
decrease of \>= 0.1 µg/kg/min catecholamine dosage to achieve MAP \> 65 mmHg in intervention group
Time frame: 48 hours
Fluid intake
reduction of fluid intake to maintain MAP \> 65 mmHg of \>= 1000 ml/24h in intervention group
Time frame: 120 hours
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf