Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy

NCT02606799 | Terminated

• 1 other identifier: KIM_CS_001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

Esophagectomy Inflammation Hemoperfusion Cytokines

Outcome Measures

Primary Outcomes (1)

• Change of interleukin-6 plasma levels

  Change of interleukin-6 plasma levels

  72 hours

Secondary Outcomes (3)

• Change in SOFA Score

  120 hours

• Change of catecholamine dose

  48 hours

• Fluid intake

  120 hours

Study Arms (2)

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

Device: CytoSorb cytokine elimination

Interventions

CytoSorb cytokine elimination DEVICE

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

Also known as: hemadsorption

CytoSorb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• abdominal-thoracic esophagectomy with radical lymphadenectomy
• post operative admission to ICU
• age \>= 18 yrs
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• CytoSorbents, Inc: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (5)

• Panagiotou A, Gaiao S, Cruz DN. Extracorporeal therapies in sepsis. J Intensive Care Med. 2013 Sep-Oct;28(5):281-95. doi: 10.1177/0885066611425759. Epub 2011 Oct 25.

  PMID: 22027760 BACKGROUND

• Bruenger F, Kizner L, Weile J, Morshuis M, Gummert JF. First successful combination of ECMO with cytokine removal therapy in cardiogenic septic shock: a case report. Int J Artif Organs. 2015 Feb;38(2):113-6. doi: 10.5301/ijao.5000382. Epub 2015 Feb 3.

  PMID: 25656010 BACKGROUND

• Kellum JA, Song M, Venkataraman R. Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-kappaB DNA binding, and improves short-term survival in lethal endotoxemia. Crit Care Med. 2004 Mar;32(3):801-5. doi: 10.1097/01.ccm.0000114997.39857.69.

  PMID: 15090965 BACKGROUND

• Basu R, Pathak S, Goyal J, Chaudhry R, Goel RB, Barwal A. Use of a novel hemoadsorption device for cytokine removal as adjuvant therapy in a patient with septic shock with multi-organ dysfunction: A case study. Indian J Crit Care Med. 2014 Dec;18(12):822-4. doi: 10.4103/0972-5229.146321.

  PMID: 25538418 BACKGROUND

• Mitzner SR, Gloger M, Henschel J, Koball S. Improvement of hemodynamic and inflammatory parameters by combined hemoadsorption and hemodiafiltration in septic shock: a case report. Blood Purif. 2013;35(4):314-5. doi: 10.1159/000351206. Epub 2013 Jul 31. No abstract available.

  PMID: 23920222 BACKGROUND

Related Links

• technical and scientific information

MeSH Terms

Conditions

Inflammation

Interventions

Hemadsorption Inhibition Tests

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serologic Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Axel Nierhaus, MD

  University Medical Center Hamburg-Eppendorf, Dep. of Critical Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: November 17, 2015
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

DE (1)