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NCT Number: NCT05242289

Cytokine Adsorption in Lung Transplantation

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.

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Key information

Conditions

Lung Transplant Failure Lung Transplant; Complications

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital

Lund, Skåne County, 224 60, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Double lung transplantation
  • Single organ failure

Exclusion criteria

  • Re-transplantation
  • Drug abuse
  • Kidney failure
  • Liver failure
  • Diabetes mellitus

Treatment and study plan

CytoSorb

Device

Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.

Primary outcomes

  1. Oxygenation at 24 hours

    Time frame: 24 hours after lung transplantation

    Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours

  2. Oxygenation at 48 hours

    Time frame: 48 hours after lung transplantation

    Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours

  3. Oxygenation at 72 hours

    Time frame: 72 hours after lung transplantation

    Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours

Secondary outcomes

  1. Diffusion capacity of the lungs (DLCO)

    Time frame: 3 months after transplantation

    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)

  2. Primary Graft dysfunction after 24 hours

    Time frame: 24 hours after lung transplantation

    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.

  3. Primary Graft dysfunction after 48 hours

    Time frame: 48 hours after lungtransplantation

    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.

  4. Primary Graft dysfunction after 72 hours

    Time frame: 72 hours after lungtransplantation

    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.

  5. Urinary output as a measure of kidney function

    Time frame: First 3 months

    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.

  6. Creatinine levels and clearance as a measure of kidney function

    Time frame: First 3 months

    To further assess the incidence of AKI, creatinine levels and its clearance will be measured.

  7. Urea levels as a measure of kidney function

    Time frame: First 3 months

    Urea levels will also be measured to assess kidney function.

  8. Rates of dialysis as a measure of kidney function

    Time frame: First 3 months

    The incidence of patients requiring dialysis will be also used to assess the frequency of AKI in the study population.

  9. Volume blood loss

    Time frame: First 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

Cytokine Adsorption in Lung Transplantation: a Randomized Controlled Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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