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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05349669
Other study ID # ANTHEAHOSPITAL12022022
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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