Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response

NCT04157647 | Unknown

• 1 other identifier: IMHeS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.

Conditions

Inflammatory Response; Chronic Renal Disease; Cardiac Surgery

Keywords

hemadsorption

Outcome Measures

Primary Outcomes (1)

• IL-6 concentration at ICU admission

  Investigators will assess the blood IL-6 concentrations between the two arms

  At day 0 after surgery

Secondary Outcomes (10)

• IL-6 concentration before cardiac surgery

  At day 0 before the cardiac surgery

• IL-6 concentration at the end of CardioPulmonary Bypass

  At day 0 at the end of the CardioPulmonary Bypass

• IL-6 concentration 2 hours after the end of CardioPulmonary Bypass

  2 hours after the end of CardioPulmonary Bypass

• IL-6 concentration 48 hours after the end of CardioPulmonary Bypass

  48 hours after the end of CardioPulmonary Bypass

• Renal function

  daily up to day 15

Study Arms (2)

CytoSorb

ACTIVE COMPARATOR

Patients assigned to this arm group will receive hemadsorption witbhCytoSorb during the surgery and in the next 24 hours after surgery.

Device: CytoSorb

Control

SHAM COMPARATOR

Patients assigned to this arm group will undergo to a normal CPB without the use of any hemoadsorption system.

Device: Control

Interventions

CytoSorb DEVICE

The hemadsorption filter will be included in the CPB circuit between the oxygenator and the venous reservoir. After cardiac surgery, the use of the filter will be continued till 24 hours after the end of surgery.

CytoSorb

Control DEVICE

No hemadsorption filter or other treatment will be included in the CPB circuit

Control

Eligibility Criteria

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

You may qualify if:

• All consecutive adult patients (age \>65 years) undergoing cardiac surgery with an anticipated CPB time duration longer than 60 minutes.
• Presence of CKD defined by a Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73 m2.
• Consent to participate to the study

You may not qualify if:

• emergency surgery
• acute infective endocarditis
• systemic infectious diseases
• previous kidney transplant
• need for contrast enhancement during surgery
• immunosuppressive or long-term corticosteroid therapies
• participation to other investigations.

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, CZ, 88100, Italy

Location

Related Publications (15)

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  PMID: 16738019 BACKGROUND

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  PMID: 10425004 BACKGROUND

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  PMID: 12776273 BACKGROUND

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  PMID: 10843245 BACKGROUND

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  PMID: 12234313 BACKGROUND

• Corral-Velez V, Lopez-Delgado JC, Betancur-Zambrano NL, Lopez-Sune N, Rojas-Lora M, Torrado H, Ballus J. The inflammatory response in cardiac surgery: an overview of the pathophysiology and clinical implications. Inflamm Allergy Drug Targets. 2015;13(6):367-70. doi: 10.2174/1871528114666150529120801.

  PMID: 26021321 BACKGROUND

• de Amorim CG, Malbouisson LM, da Silva FC Jr, Fiorelli AI, Murakami CK, Carmona MJ. Leukocyte depletion during CPB: effects on inflammation and lung function. Inflammation. 2014 Feb;37(1):196-204. doi: 10.1007/s10753-013-9730-z.

  PMID: 24092406 BACKGROUND

• Ilmakunnas M, Pesonen EJ, Ahonen J, Ramo J, Siitonen S, Repo H. Activation of neutrophils and monocytes by a leukocyte-depleting filter used throughout cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2005 Apr;129(4):851-9. doi: 10.1016/j.jtcvs.2004.07.061.

  PMID: 15821654 BACKGROUND

• Wiegele M, Krenn CG. Cytosorb in a patient with Legionella pneumonia-associated rhabdomyolysis: a case report. ASAIO J. 2015 May-Jun;61(3):e14-6. doi: 10.1097/MAT.0000000000000197. No abstract available.

  PMID: 25635933 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

• Hetz H, Berger R, Recknagel P, Steltzer H. Septic shock secondary to beta-hemolytic streptococcus-induced necrotizing fasciitis treated with a novel cytokine adsorption therapy. Int J Artif Organs. 2014 May;37(5):422-6. doi: 10.5301/ijao.5000315. Epub 2014 Apr 17.

  PMID: 24811308 BACKGROUND

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  PMID: 19192755 BACKGROUND

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• Baumann A, Buchwald D, Annecke T, Hellmich M, Zahn PK, Hohn A. RECCAS - REmoval of Cytokines during CArdiac Surgery: study protocol for a randomised controlled trial. Trials. 2016 Mar 12;17(1):137. doi: 10.1186/s13063-016-1265-9.

  PMID: 26971164 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Serraino, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe F Serraino, MD

CONTACT

0039 0961 3647033; filiberto@live.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: November 8, 2019
• Study Start: November 15, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 15, 2021
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After scientific publication
• Access Criteria: On reasonable request

Locations

IT (1)