Clinical trial NCT05349669: Jafron Haemoadsorption During Cardiopulmonary Bypass
Official title: Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cytokine Release Syndrome
Lead sponsor: Anthea Hospital Bari
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this context the investigators introduce the study design for multi-centre pilot randomized report in 40 patients undergoing elective CPB procedures with an expected time \>120 minutes for each extracorporeal procedure. Patients will be randomly allocated to either standard of care (n = 20) or Jafron HA(n = 20) during cardiopulmonary bypass (CPB). The primary outcome will be the difference between the two groups in cytokines levels (IL-2, IL-6,TNF-α, IFN gamma) and secondary parameters (Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Lymphocytes, Monocytes, Eosinophils, Basophils) will measured at anaesthesia induction, at the endof CPB , Primary outcomes: hemodynamics with or without vasoconstrictors use, the mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours). This prospectivemulti-centre randomized controlled report will take place in two Centres: Anthea Hospital, GVMCare \& Research, Bari, Italy; Virgen de la Arrixaca University Hospital, Murcia, Spain; between May 2022 and September 2022. The target population per centre will include (n=20) patients; will beallocate for each center to either standard of care (n = 10) or Jafron HA (n = 10) planned for elective cardiac surgery with increased risk of cytokine release.

Eligibility criteria: 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

Primary outcomes:
measure: cytokines levels
timeFrame: 1 hour before start of the cardiopulmonary bypass
measure: cytokines levels
timeFrame: 10 minutes after stop the cardiopulmonary bypass
measure: Hemodynamics supports
timeFrame: 10 minutes after stop of the cardiopulmonary bypass
measure: Post-operative ITEMS in intensive care unit
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Markers levels
timeFrame: 1 day before start of the cardiopulmonary bypass
measure: Markers
timeFrame: 1 day after stop the cardiopulmonary bypass
measure: Hemodynamics supports
timeFrame: 1 hour after stop the cardiopulmonary bypass
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Anthea Hospital
state: Apulian
Study officials:
References: