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Trial record 27 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Increased Adsorption Membranes During Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT02518087
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
Germans Trias i Pujol Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Baxter Healthcare Corporation
Information provided by (Responsible Party):
JOSE LUIS PEREZ FERNANDEZ, Hospital Universitari de Bellvitge

Brief Summary:

Our project intends to reduce cardiac surgery associated - acute kidney injury (CS-AKI) in non emergent patients with the use of an increased adsorption membrane (oXiris®) connected to the cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a randomized and controlled multicentre trial that includes recruiting centres with a long experience in cardiac surgery with CPB.

The primary endpoint of the project is to evaluate the ability of oXiris® to reduce the incidence of CS-AKI in patients undergoing non emergent cardiac surgery with an expected CPB time of more than 60 minutes (doble valve replacement or valve replacement plus coronary artery bypass graft). With the goal of reducing by 10% (from 25 to 15%) the risk of CS-AKI during the first postoperative week a sample size of 340 patients has been calculated.

Secondary endpoints are two; first, to evaluate the effect of using oXiris® on survival, clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and after CPB; and second, to assess the predictive value for CS-AKI of some new biomarkers, such as uNAD (urinary nicotinamide adenine dinucleotide).


Condition or disease Intervention/treatment Phase
Cardiopulmonary Bypass Cardiac Surgery Associated - Acute Kidney Injury Systemic Inflammatory Response Syndrome Acute Kidney Injury Device: oXiris® Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Increased Adsorption Membranes During Cardiopulmonary Bypass. A Randomized Controlled Trial to Evaluate Impact of oXiris® Membrane in Cardiac Surgery Associated Acute Kidney Injury
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: CPB-oXiris®
Non emergent cardiac surgery patients requiring expected CPB time > 60 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).
Device: oXiris®

oXiris® membrane set is composed of a 1.5 m2 copolymer of acrylonitrile and sodium methylsulfonate (AN 69) with polyethylenimine treated surface and adhered heparin during set´s fabrication [oXiris® (Baxter Gambro)].

Blood flow between 200-250 mL/min will be derivatised from the CPB circuit (arterial positive pressure line just after the oxygenator) into the PrismafleX eXeed™, so that it all flows thru the oXiris® membrane and returned to the CPB circuit into the venous reservoir just before the oxygenator. oXiris® membrane will be only employed for adsorption (neither convection nor diffusion will be performed) during all CPB time.


No Intervention: CPB-Standard
Non emergent cardiac surgery patients requiring expected CPB time > 60 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).



Primary Outcome Measures :
  1. Non presence of AKI-CS within the first 7 days after cardiac surgery. [ Time Frame: 7 days ]
    Participants who underwent cardiac surgery with no AKI-CS within the first 7 days after cardiac surgery. AKI-CS will be defined as at least AKI stage≥1 (according to AKI KDIGO classification) during the first 7 days of cardiac surgery. Patients with previous mild chronic kidney disease (CKD) will also be classified as AKI-CS according to changes of creatinine respect to baseline creatinine or urine output decrease within the first 7 days after cardiac surgery.


Secondary Outcome Measures :
  1. 90 day survival after cardiac surgery. [ Time Frame: 90 days ]
    90 day survival evaluation after cardiac surgery.

  2. ICU length of stay after cardiac surgery. [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 days. ]
    ICU length of stay evaluation after cardiac surgery.

  3. Cytokine circulatory levels during CPB and up to 24 hours after surgery. [ Time Frame: First 24 hours after cardiac surgery. ]

    Cytokine circulatory levels during CPB and up to 24 hours after surgery. Cytokine removal: IL-1, IL-6, IL-8, IL-10, IL-18, TNFα, MCP-1, HMBP-1, RANTES, and GROα levels will be determined in plasma.

    Determinations will be measured baseline (0hours), and at T1 (CPB end), T2 (ICU admission), and T3 (24hours).


  4. Urinary and blood levels of NAD values after cardiac surgery. [ Time Frame: First 24 hours after cardiac surgery. ]
    Urinary and blood levels of NAD will be at measured baseline (0hours), and at T1 (CPB end), T2 (ICU admission), and T3 (24hours).

  5. Composite Creatinine and Urine output after cardiac surgery. [ Time Frame: 7 days after cardiac surgery. ]
    Renal function in terms of creatinine and urine output will be registered every 24h after cardiac surgery up to the first week. KDIGO AKI score will be calculated according to these two items.

  6. Hospital length of stay after cardiac surgery. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week. ]
    Hospital length of stay evaluation after cardiac surgery.

  7. LPS circulatory levels during CPB and up to 24 hours after surgery. [ Time Frame: First 24 hours after cardiac surgery. ]
    Lipopolysaccharide (LPS) removal: LPS levels will be determined in plasma. Determinations will be measured baseline (0hours), and at T1 (CPB end), T2 (ICU admission), and T3 (24hours).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with more than 18 years old.
  • Non emergent cardiac surgery patients requiring expected CPB time > 60 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).
  • Written informed consent from patient or legal surrogates.

Exclusion Criteria:

  • Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
  • Autoimmune disorder.
  • Transplant receptor.
  • Advanced Chronic Kidney Disease (CKD 4 or 5).
  • Renal replacement therapy in the last 90 days.
  • Documented intolerance to study device.
  • Inclusion in other ongoing study within the last 30 days.
  • Pregnancy.
  • Coexisting illness with a high probability of death (inferior to 6 months).

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): NCT02518087


Contacts
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Contact: Xosé L Perez-Fernandez, MD +34 93 2607521 josep@bellvitgehospital.cat
Contact: Joan Sabater Riera, MD PhD +34 93 2607511 jsabater70@gmail.com

Locations
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Spain
Hospital German Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Ana Campos, MD PhD       anacamgom@gmail.com   
Sub-Investigator: Marc Ayala Gallardo, MD         
Sub-Investigator: Marius Sánchez Satorra, MD         
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Xosé L. Pérez Fernández, MD    +34 93 2607521    josep@bellvitgehospital.cat   
Principal Investigator: Joan Sabater, MD PhD         
Principal Investigator: Xosé Pérez, MD         
Sub-Investigator: Enric Boza, MD         
Sub-Investigator: Albert Gil, MD         
Sub-Investigator: Albert Miralles, MD         
Sub-Investigator: Luisa Rivera, MD         
Sub-Investigator: Fabrizio Sbraga, MD         
Sub-Investigator: Jacobo Toscano, MD         
Principal Investigator: Erika Plata-Menchaca, MD         
Sub-Investigator: Marcos Potocnik, MD         
Sub-Investigator: Karina Osorio, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Contact: Jorge Ordoñez, MD PhD       jordonez@santpau.cat   
Contact: Antoni Betbesé, MD PhD         
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Germans Trias i Pujol Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Joan Sabater Riera, MD PhD Hospital Universitari de Bellvitge
Principal Investigator: Xosé L Perez-Fernandez, MD Hospital Universitari de Bellvitge
Study Chair: Kathleen D Liu, MD PhD University California San Francisco

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Responsible Party: JOSE LUIS PEREZ FERNANDEZ, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02518087     History of Changes
Other Study ID Numbers: SIRAKI 02-2015
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Keywords provided by JOSE LUIS PEREZ FERNANDEZ, Hospital Universitari de Bellvitge:
CPB
oXiris®
CS-AKI
SIRS
Cytokines
LPS
AKI
Additional relevant MeSH terms:
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Acute Kidney Injury
Systemic Inflammatory Response Syndrome
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Inflammation
Pathologic Processes
Shock