Inflammation
Conditions
Keywords
Esophagectomy Inflammation Hemoperfusion Cytokines
Brief summary
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.
Detailed description
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.
Interventions
DEVICECytoSorb 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
Sponsors
CytoSorbents, Inc
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* abdominal-thoracic esophagectomy with radical lymphadenectomy * post operative admission to ICU * age \>= 18 yrs * written informed consent
Exclusion criteria
* Participation in another interventional trial * pregnancy or lactation * systemic medication with high dose steroids and/or immunosuppressants and/or radiotherapy during the last 3 months * known diseases of the immune system (benign and malign) * contraindications for extracorporeal therapy * Thrombocytopenia \< 50\*10\^9/l * therapy limitations (DNR), moribund status * missing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of interleukin-6 plasma levels | 72 hours | Change of interleukin-6 plasma levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SOFA Score | 120 hours | decrease of \>= 2 score points in the intervention group |
| Change of catecholamine dose | 48 hours | decrease of \>= 0.1 µg/kg/min catecholamine dosage to achieve MAP \> 65 mmHg in intervention group |
| Fluid intake | 120 hours | reduction of fluid intake to maintain MAP \> 65 mmHg of \>= 1000 ml/24h in intervention group |
Countries
Germany
Outcome results
None listed