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Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (REMOTE)

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.
 
ClinicalTrials.gov Identifier: NCT03104179
Recruitment Status : Unknown
Verified March 2017 by PD Dr. med. Giuseppe Santarpino, Klinikum Nürnberg.
Recruitment status was:  Not yet recruiting
First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
CytoSorbents, Inc
Information provided by (Responsible Party):
PD Dr. med. Giuseppe Santarpino, Klinikum Nürnberg

Study Description
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Brief Summary:

In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.

They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.

Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.

These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.

There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.

Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.


Condition or disease Intervention/treatment Phase
Extracorporeal Circulation Hemofiltration Device: Cytosorb Adsorber Not Applicable

Detailed Description:

In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.

They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.

Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.

These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.

There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.

Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.

Official Title: Removal of Cytokines in patients undergoing cardiac surgery with CPB ( The REMOTE Study)

Study type: Interventional Study design: randomized, controlled Endpoint Classification: Efficacy study Interventional Model: Parallel assignment Masking: Single blinding ( Subject) Primary purpose: Treatment

Patients who have an elective cardiac surgery with an expected CPB duration > 75 min ( e.g. valve surgery, CABG, combined procedures, redo) will be enrolled into the study after a giving informed consent.

Selection of patients are directed by randomization. Patient which drop out will be replaced.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (The REMOTE Study)
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
CPB with Cytosorb
 Device: Cytosorb Adsorber
Cytokine adsorption during CPB
No Intervention: Control
CPB without Cytosorb (Control)


Outcome Measures
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Primary Outcome Measures :
  1. Cytokine levels following CPB [ Time Frame: 72 hours ]
    Evaluation of cytokine adsorber effect on cytokine levels intra- and post


Secondary Outcome Measures :
  1. Intra- and postoperative catecholamine dosages [ Time Frame: until ICU discharge, expected average 4 days ]
    Impact of intraoperative Cytokine adsorption on hemodynamic stability

  2. postoperative renal failure necessitating RRT [ Time Frame: until ICU discharge, expected average 4 days ]
    Impact of intraoperative Cytokine adsorption on postoperative organ function

  3. Level of ferritin [ Time Frame: 72 hours ]
    Impact of intraoperative Cytokine adsorption on iron metabolism

  4. Level of transferrin [ Time Frame: 72 hours ]
    Impact of intraoperative Cytokine adsorption on iron metabolism

  5. Level of haptoglobin [ Time Frame: 72 hours ]
    Impact of intraoperative Cytokine adsorption on iron metabolism

  6. Length of ICU stay [ Time Frame: until discharge from ICU, expected average 4 days ]
    Impact of intraoperative Cytokine adsorption on postoperative patient course

  7. Length of hospital stay [ Time Frame: up to hospital discharge, expected average 14 days ]
    Impact of intraoperative Cytokine adsorption on postoperative patient course


Other Outcome Measures:
  1. Mortality [ Time Frame: 28 days ]
    Impact of intraoperative Cytokine adsorption on postoperative patient course


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective cardiac surgery with CPB
  • Signed informed consent
  • CPB time > 75 min.
  • Comorbidities:
  • diabetes mellitus
  • CHF, NYHA class 1 and 2
  • liver dysfunction (1, 2)
  • kidney dysfunction (1, 2)
  • hypertension
  • arteriosclerosis

Exclusion Criteria:

  • Age < 65 years
  • Declined informed consent
  • Planed temperature < 32 C
  • Emergency surgery
  • Preexisting renal replacement therapy
  • Preexisting kidney transplantation
  • Administration of immunosuppressants like steroids
  • AIDS with CD 4 < 200/
  • Participation in other trials
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03104179


Contacts
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Contact: Giuseppe Santarpino, MD +4909113985441 giuseppe.santarpino@klinikum-nuernberg.de
Contact: Theodor Fischlein, MD +4909113985441 theodor.fischlein@klinikum-nuernberg.de

Locations
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Germany
Klinikum Nürnberg - Nuremberg Hospital
Nuremberg, Bavaria, Germany, 90471
Contact: Giuseppe Santarpino, MD    +4909113985441    giuseppe.santarpino@klinikum-nuernberg.de   
Contact: theodor Fischlein, MD    +4909113985441    theodor.fischlein@klinikum-nuernberg.de   
Sub-Investigator: Husam Alnahas, MD         
Sponsors and Collaborators
Klinikum Nürnberg
CytoSorbents, Inc
More Information
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Publications:

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Responsible Party: PD Dr. med. Giuseppe Santarpino, PD, Dr. med, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT03104179    
Other Study ID Numbers: 1_15B
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No