Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy (EXCESS)
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|ClinicalTrials.gov Identifier: NCT02606799|
Recruitment Status : Unknown
Verified November 2015 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was: Not yet recruiting
First Posted : November 17, 2015
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Device: CytoSorb cytokine elimination||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy - a Randomized Study (EXCESS)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||September 2016|
No Intervention: Standard Care
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
Other Name: hemadsorption
- Change of interleukin-6 plasma levels [ Time Frame: 72 hours ]
- Change in SOFA Score [ Time Frame: 120 hours ]decrease of >= 2 score points in the intervention group
- Change of catecholamine dose [ Time Frame: 48 hours ]decrease of >= 0.1 µg/kg/min catecholamine dosage to achieve MAP > 65 mmHg in intervention group
- Fluid intake [ Time Frame: 120 hours ]reduction of fluid intake to maintain MAP > 65 mmHg of >= 1000 ml/24h in intervention group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606799
|Contact: Stefan Kluge, MD||+49 40 7410 email@example.com|
|Contact: Axel Nierhaus, MD||+49 40 7410 firstname.lastname@example.org|
|University Medical Center Hamburg-Eppendorf||Not yet recruiting|
|Hamburg, Germany, 20251|
|Contact: Stefan Kluge, MD +49 40 7410 57010 email@example.com|
|Contact: Axel Nierhaus, MD +49 40 7410 55325 firstname.lastname@example.org|
|Principal Investigator: Axel Nierhaus, MD|
|Principal Investigator:||Axel Nierhaus, MD||University Medical Center Hamburg-Eppendorf, Dep. of Critical Care|