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

June 29, 2022 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • hemadsorption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of interleukin-6 plasma levels
Time Frame: 72 hours
Change of interleukin-6 plasma levels
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SOFA Score
Time Frame: 120 hours
decrease of >= 2 score points in the intervention group
120 hours
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
48 hours
Fluid intake
Time Frame: 120 hours
reduction of fluid intake to maintain MAP > 65 mmHg of >= 1000 ml/24h in intervention group
120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

CytoSorbents, Inc

Investigators

  • Principal Investigator: Axel Nierhaus, MD, University Medical Center Hamburg-Eppendorf, Dep. of Critical Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIM_CS_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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