Device: CytoSorb: Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.
Study summary
Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality. PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival.
The present study is a randomized controlled study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
• Eligibility to undergo double lung transplantation at either trial site
Exclusion Criteria:
1. Age \<18 years
2. Previous organ transplantation
3. Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:
1. Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation.
2. Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation.
4. Non-consent
Primary outcome measure(s)
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. — First 72 hours after lung transplantation Higest value of oxygenation expressed as the PaO2/FiO2 ratio.
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 24 hours — 24 hours after lung transplantation Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 48 hours — 48 hours after lung transplantation Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 72 hours — 72 hours after lung transplantation Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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