Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy (EXCESS)

Universitätsklinikum Hamburg-Eppendorf

Status: Terminated

Conditions: Inflammation

Treatments: Device: CytoSorb cytokine elimination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02606799

KIM_CS_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Standard Care

No Intervention group

Description:

intensive care therapy according to international standards and following local SOPs, including fluid therapy, mechanical ventilation, catecholamine therapy and other pharmacotherapy as required

CytoSorb

Experimental group

Description:

all of the above, plus extracorporeal hemadsorption therapy (CytoSorbents Adsorber cartridge) using continuous veno-venous hemofiltration (citrate anticoagulation) CytoSorb cytokine elimination

Treatment:

Device: CytoSorb cytokine elimination