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Clinical Trials/NCT02606799
NCT02606799TerminatedNot Applicable

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country5 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
1
Primary Endpoint
Change of interleukin-6 plasma levels

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Standard Care

No Intervention

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

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

Intervention: CytoSorb cytokine elimination (Device)

Outcomes

Primary Outcomes

Change of interleukin-6 plasma levels

Time Frame: 72 hours

Change of interleukin-6 plasma levels

Secondary Outcomes

  • Change of catecholamine dose(48 hours)
  • Change in SOFA Score(120 hours)
  • Fluid intake(120 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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