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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02606799
First Posted: November 17, 2015
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CytoSorbents, Inc
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  Purpose
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.

Condition Intervention Phase
Inflammation Device: CytoSorb cytokine elimination Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy - a Randomized Study (EXCESS)

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Change of interleukin-6 plasma levels [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: December 2015
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: CytoSorb
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Stefan Kluge, MD +49 40 7410 57010 s.kluge@uke.de
Contact: Axel Nierhaus, MD +49 40 7410 55325 nierhaus@uke.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20251
Contact: Stefan Kluge, MD    +49 40 7410 57010    s.kluge@uke.de   
Contact: Axel Nierhaus, MD    +49 40 7410 55325    nierhaus@uke.de   
Principal Investigator: Axel Nierhaus, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
CytoSorbents, Inc
Investigators
Principal Investigator: Axel Nierhaus, MD University Medical Center Hamburg-Eppendorf, Dep. of Critical Care
  More Information

Additional Information:
Publications:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02606799     History of Changes
Other Study ID Numbers: KIM_CS_001
First Submitted: October 1, 2015
First Posted: November 17, 2015
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Esophagectomy Inflammation Hemoperfusion Cytokines

Additional relevant MeSH terms:
Inflammation
Pathologic Processes