An interventional study of CytoSorb in Lung Transplant Failure and Lung Transplant; Complications, sponsored by Lund University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Lund University Hospital · Not applicable, Interventional, and Treatment
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 (2). 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 pilot study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.
Early intolerance to the newly transplanted lung starts at the time of transplantation and results in PGD driven by an intense inflammatory response. Cytokines play a critical role as signaling molecules that initiate, amplify, and maintain inflammatory responses both locally and systemically. The use of cytokine filtration devices to target middle- and low-molecular weight molecules has been shown to reduce levels of a diverse number of cytokines. These results have been demonstrated in the in vitro reduction of pathogen-associated molecular pattern molecules (PAMPS) and damage associated molecular patterns (DAMPS) as well as in in vivo studies involving orthotopic heart transplantation and kidney transplantation. Cytokine adsorption has been used successfully in clinical applications to both heart and kidney transplantation.
The present study is a randomized controlled pilot study which aims to collect preliminary data on the efficacy of a medical device through the comparison of patients undergoing LTx with and without cytokine adsorption.
Lund University Hospital is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment using the medical "cytokine adsorption" device in conjunction with lung transplantation
Device: CytoSorb
No additional treatment in conjunction with lung transplantation
Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.
Oxygenation at 24 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours
Time frame: 24 hours after lung transplantation
Oxygenation at 48 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours
Time frame: 48 hours after lung transplantation
Oxygenation at 72 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
Time frame: 72 hours after lung transplantation
Diffusion capacity of the lungs (DLCO)
The primary function of the lungs is oxygenation of the blood and exhalation of carbon dioxide (CO2) from the blood. The ability of the lungs to perform this depends on a good alveolar ventilation, an even relationship between perfusion and ventilation, and good diffusion potential for oxygen (O2) and CO2 between alveolar, capillary and hemoglobin. This outcome will be measured through the diffusing capacity for carbon monoxide (DLCO)
Time frame: 3 months after transplantation
Primary Graft dysfunction after 24 hours
Primary graft dysfunction (PGD) 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 over the first 72 hours after transplantation and is defined by evaluation of both the PaO2/FiO2 ratio and presence of lung edema on chest x-ray.
Time frame: 24 hours after lung transplantation
Primary Graft dysfunction after 48 hours
PGD must also be assessed throughout the 72 hour period following completion of the transplantation and as such, this outcome will consist of the evaluation for PGD in the recipient 48 hours post-transplantation.
Time frame: 48 hours after lungtransplantation
Primary Graft dysfunction after 72 hours
PGD must also be assessed throughout the 72 hour period following completion of the transplantation and as such, this outcome will consist of the evaluation for PGD in the recipient 72 hours post-transplantation.
Time frame: 72 hours after lungtransplantation
Urinary output as a measure of kidney function
Kidney function is often impaired in transplant subjects due to the surgery itself but also secondary to drugs. The degree of acute kidney injury (AKI) can be assessed in part through measure of the urinary output.
Time frame: First 3 months
Creatinine levels and clearance as a measure of kidney function
To further assess the incidence of AKI, creatinine levels and its clearance will be measured.
Time frame: First 3 months
Urea levels as a measure of kidney function
Urea levels will also be measured to assess kidney function.
Time frame: First 3 months
Rates of dialysis as a measure of kidney function
The incidence of patients requiring dialysis will be also used to assess the frequency of AKI in the study population.
Time frame: First 3 months
Volume blood loss
Given the nature of the transplantation itself as a major surgery, blood loss is expected after surgery and the volume of blood loss (mL) after surgery will be measured as a surgical outcome.
Time frame: First 24 hours
Plan to share: Undecided
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Lund University Hospital