Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy

Inflammation Clinical Trial

— EXCESS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02606799
• Other study ID #: KIM_CS_001
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: June 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	CytoSorbents, Inc

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of interleukin-6 plasma levels	Change of interleukin-6 plasma levels	72 hours
Secondary	Change in SOFA Score	decrease of >= 2 score points in the intervention group	120 hours
Secondary	Change of catecholamine dose	decrease of >= 0.1 µg/kg/min catecholamine dosage to achieve MAP > 65 mmHg in intervention group	48 hours
Secondary	Fluid intake	reduction of fluid intake to maintain MAP > 65 mmHg of >= 1000 ml/24h in intervention group	120 hours

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