Jafron Haemoadsorption During Cardiopulmonary Bypass

Cytokine Release Syndrome Clinical Trial

— JAFRONCPB  

Official title:

Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349669
• Other study ID #: ANTHEAHOSPITAL12022022
• Status: Completed
• Phase: Phase 2
• Start date: May 30, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: February 2023
• Source: Anthea Hospital Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cytokine Release Syndrome

Intervention

Drug:
• Jafron use during CPB
Use of filter Jafron during CPB

Locations

Country	Name	City	State
Italy	Anthea Hospital	Bari	Apulian

Sponsors (1)

Lead Sponsor	Collaborator
Anthea Hospital Bari

Country where clinical trial is conducted

Italy, 

Outcome

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