Cardiopulmonary Bypass Clinical Trial
Official title:
Clinical Trial to Evaluate Facticity and Security for the Use of an Increased Adsorption Capacity Membrane (oXiris®) During Cardiopulmonary Bypass Surgery
NCT number | NCT02398019 |
Other study ID # | SIRAKI 01-2014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | October 2015 |
Verified date | August 2018 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise (vasodilatation plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction is a major adverse complication after CPB surgery. Investigators hypothesize that the use of an increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical complexity. The safe use of OXIRIS® will reduce cytokine circulatory levels therefore decreasing SIRS and its systemic effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®) could potentially present less cardiac surgery-associated acute kidney injury (CSA-AKI), and lower intensive care unit (ICU) and hospital length of stay.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with more than 18 years old. - Non emergent cardiac surgery requiring CPB. - Written informed consent from patient or legal surrogates Exclusion Criteria: - Missing informed consent. - Planned CPB hypothermia <32ºC or cardiac arrest. - Emergency surgery. - Acute infective endocarditis. - 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 (RRT) 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge | Gambro Renal Products, Inc. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety with the use of CPB. Number of complications reported. | Patients who underwent cardiac surgery with no related complications due to CPB (0 complications). Complications will be defined as those adverse effects related to technique that need an extra attention out of standard proceedings. | 24 hours | |
Primary | Cell-free serum hemoglobin | Cell-free serum hemoglobin concentration will be measured in order to evaluate intravascular hemolysis. Determinations will be measured at T1 (CPB end), and T3 (24hours). |
24 hours | |
Secondary | Cytokine circulatory levels during CPB and up to 24 hours after surgery. | Cytokine circulatory levels during CPB and up to 24 hours after surgery. Cytokine removal: interleukin-1ß (IL-1ß), tumor necrosis factor a (TNF-a), interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-10 (IL-10) levels will be determined in plasma. Determinations will be measured baseline (0hours), and at T1 (CPB end), T2 (ICU admission), and T3 (24hours). |
24 hours | |
Secondary | Creatinine and Urine output 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. | 7 days |
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