Cytokine Release Syndrome Clinical Trial
— JAFRONCPBOfficial title:
Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report
Verified date | February 2023 |
Source | Anthea Hospital Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. Jafron is a device designed to remove cytokine from the blood using haemoadsorption (HA). This preliminary report aims to evaluate the potential of Jafron to decrease peri-operative cytokine levels in cardiac surgery.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 15, 2022 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 100 Years |
Eligibility | Inclusion Criteria : - elective cardiac surgery under CPB - double valve replacement or a complex surgery with an expected CPB duration > 120 min - redo cardiac surgery Exclusion criteria: - end-stage renal disease (dialysis dependence) - active infectious endocarditis - emergency or off-pump procedure - prescription of non-steroidal antiinflammatory medication (except for low-dose aspirin) or corticosteroids within 7 days - enrolment in another conflicting study - administration of human albumin during CPB |
Country | Name | City | State |
---|---|---|---|
Italy | Anthea Hospital | Bari | Apulian |
Lead Sponsor | Collaborator |
---|---|
Anthea Hospital Bari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cytokines levels | IL-2, IL-6,TNF-a, IFN gamma | 1 hour before start of the cardiopulmonary bypass | |
Primary | cytokines levels | IL-2, IL-6,TNF-a, IFN gamma, | 10 minutes after stop the cardiopulmonary bypass | |
Primary | Hemodynamics supports | vasoconstrictors use or not use | 10 minutes after stop of the cardiopulmonary bypass | |
Primary | Post-operative ITEMS in intensive care unit | mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours) | 3 days after surgery | |
Secondary | Markers levels | Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils | 1 day before start of the cardiopulmonary bypass | |
Secondary | Markers | Concentration of Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Aptoglobin, Cell free Hemoglobin Lymphocytes, Monocytes, Eosinophils, Basophils | 1 day after stop the cardiopulmonary bypass | |
Secondary | Hemodynamics supports | Need of vasoconstrictors | 1 hour after stop the cardiopulmonary bypass |
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