JMIR Publications

ABSTRACT

Background:

Despite improvements in lung transplantation (LTx), primary graft dysfunction (PGD) remains the leading cause of early mortality and precipitates chronic lung allograft dysfunction, the chief factor in late mortality after Ltx. PGD develops within the first 72 hours and impairs the oxygenation capacity of the lung, measured as partial pressure of oxygen/fraction of inspired oxygen (P/F ratio). Increasing the P/F ratio is thus critical and has a direct impact on survival. Yet, treatments for PGD are lacking. In a proof-of-concept pre-clinical porcine model of LTx, cytokine filtration improved oxygenation and decreased PGD. In a feasibility study we successfully treated LTx patients with cytokine filtration (NCT05242289).

Objective:

The purpose of this clinical trial is to demonstrate the superiority of cytokine filtration in improving LTx success, based on its effects on oxygenation ratio, plasma levels of inflammatory markers, PGD incidence and severity, lung function, kidney function, survival, and quality of life compared with standard treatment with no cytokine filtration.

Methods:

This Swedish national interventional, randomised controlled study of 116 patients will examine whether cytokine filtration in conjunction with LTx, administered for 12 hours in the first 24 hours following LTx improves outcomes.

Results:

Results/Planned outcome: Recruitment of patients will start after a site initiation visit on the 28 of August 2023. Primary outcome: Oxygenation ratio, defined as highest P/F ratio within 72 h after LTx.

Conclusions:

We believe that cytokine filtration will improve successful LTx rates, improve lung transplant care and increase survival. Clinical Trial: Clinicaltrials.gov registration number: NCT05526950. Medical Products Agency, Sweden (Dnr 5.1- 2023-23105).