Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy
- Conditions
- Inflammation
- Interventions
- Device: CytoSorb cytokine elimination
- Registration Number
- NCT02606799
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- abdominal-thoracic esophagectomy with radical lymphadenectomy
- post operative admission to ICU
- age >= 18 yrs
- written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CytoSorb CytoSorb cytokine elimination all of the above, plus extracorporeal hemadsorption therapy (CytoSorbents Adsorber cartridge) using continuous veno-venous hemofiltration (citrate anticoagulation) CytoSorb cytokine elimination
- Primary Outcome Measures
Name Time Method Change of interleukin-6 plasma levels 72 hours Change of interleukin-6 plasma levels
- Secondary Outcome Measures
Name Time Method Change of catecholamine dose 48 hours decrease of \>= 0.1 µg/kg/min catecholamine dosage to achieve MAP \> 65 mmHg in intervention group
Change in SOFA Score 120 hours decrease of \>= 2 score points in the intervention group
Fluid intake 120 hours reduction of fluid intake to maintain MAP \> 65 mmHg of \>= 1000 ml/24h in intervention group
Trial Locations
- Locations (1)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany