Lung Transplant FailureNCT05242289
Cytokine Adsorption in Lung Transplantation
A study testing CytoSorb in people with Lung Transplant Failure and Lung Transplant; Complications, run by Lund University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplant Failure, Lung Transplant; Complications
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 2 Mar 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Double lung transplantation
- Single organ failure
Who cannot join
- Re-transplantation
- Drug abuse
- Kidney failure
- Liver failure
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytokine Adsorption in Lung Transplantation: a Randomized Controlled Pilot Study
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.
Read the detailed description
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.
- Being tested
- CytoSorb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Active comparator | Treatment using the medical "cytokine adsorption" device in conjunction with lung transplantation Receives: Device: CytoSorb |
| Non-treated | No intervention | No additional treatment in conjunction with lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation at 24 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours
Measured: 24 hours after lung transplantation
Oxygenation at 48 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours
Measured: 48 hours after lung transplantation
Oxygenation at 72 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
Measured: 72 hours after lung transplantation
Secondary outcomes (9)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 3 months
Urea levels as a measure of kidney function
Urea levels will also be measured to assess kidney function.
Measured: 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.
Measured: 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.
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start2 Mar 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The model consists of a randomized controlled pilot in human patients using a "cytokine adsorption" device. Lung transplant recipients are randomized to either the treatment group which undergoes cytokine adsorption using the medical device compared to the control group which has not received the cytokine adsorber.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Lindstedt, Lund University Hospital
- Investigators
- Sandra Lindstedt, MD, PhD, Principal investigator, Skånes universitetssjukhus Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242289
- Sponsor's protocol ID
- LUSorb
- Status last verified
- Sep 2023
- First submitted
- 22 Jan 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Niroomand A, Hirdman G, Olm F, Lindstedt S. Current Status and Future Perspectives on Machine Perfusion: A Treatment Platform to Restore and Regenerate Injured Lungs Using Cell and Cytokine Adsorption Therapy. Cells. 2021 Dec 29;11(1):91. doi: 10.3390/cells11010091.
PubMed 35011653Ghaidan H, Fakhro M, Lindstedt S. Impact of allograft ischemic time on long-term survival in lung transplantation: a Swedish monocentric study. Scand Cardiovasc J. 2020 Oct;54(5):322-329. doi: 10.1080/14017431.2020.1781240. Epub 2020 Jun 23.
PubMed 32573283Fakhro M, Ingemansson R, Skog I, Algotsson L, Hansson L, Koul B, Gustafsson R, Wierup P, Lindstedt S. 25-year follow-up after lung transplantation at Lund University Hospital in Sweden: superior results obtained for patients with cystic fibrosis. Interact Cardiovasc Thorac Surg. 2016 Jul;23(1):65-73. doi: 10.1093/icvts/ivw078. Epub 2016 Apr 6.
PubMed 27052747Lindstedt S, Silverborn M, Lannemyr L, Pierre L, Larsson H, Grins E, Hyllen S, Dellgren G, Magnusson J. Design and Rationale of Cytokine Filtration in Lung Transplantation (GLUSorb): Protocol for a Multicenter Clinical Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 13;12:e52553. doi: 10.2196/52553.
PubMed 37855706
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Adsorption in Lung Transplantation: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05242289
- Acronym / sponsor ID
- LUSorb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The model consists of a randomized controlled pilot in human patients using a "cytokine adsorption" device. Lung transplant recipients are randomized to either the treatment group which undergoes cytokine adsorption using the medical device compared to the control group which has not received the cytokine adsorber.
| Arm | Type | Receives |
|---|---|---|
| Treated | Active comparator | Device: CytoSorbTreatment using the medical "cytokine adsorption" device in conjunction with lung transplantation |
| Non-treated | No intervention | –No additional treatment in conjunction with lung transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Double lung transplantation
- Single organ failure
Key exclusion criteria (5 listed)
- Re-transplantation
- Drug abuse
- Kidney failure
- Liver failure
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorbMedical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation. | Device | Treated |
Primary outcome
Oxygenation at 24 hours
Time frame: 24 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours
Oxygenation at 48 hours
Time frame: 48 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours
Oxygenation at 72 hours
Time frame: 72 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
9 secondary outcomes
Diffusion capacity of the lungs (DLCO)
Time frame: 3 months after transplantation
Primary Graft dysfunction after 24 hours
Time frame: 24 hours after lung transplantation
Primary Graft dysfunction after 48 hours
Time frame: 48 hours after lungtransplantation
Primary Graft dysfunction after 72 hours
Time frame: 72 hours after lungtransplantation
Urinary output as a measure of kidney function
Time frame: First 3 months
Creatinine levels and clearance as a measure of kidney function
Time frame: First 3 months
Urea levels as a measure of kidney function
Time frame: First 3 months
Rates of dialysis as a measure of kidney function
Time frame: First 3 months
Volume blood loss
Time frame: First 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Results publication: PubMed 35011653Niroomand A, Hirdman G, Olm F, Lindstedt S. Current Status and Future Perspectives on Machine Perfusion: A Treatment Platform to Restore and Regenerate Injured Lungs Using Cell and Cytokine Adsorption Therapy. Cells. 2021 Dec 29;11(1):91. doi: 10.3390/cells11010091.
- Results publication: PubMed 32573283Ghaidan H, Fakhro M, Lindstedt S. Impact of allograft ischemic time on long-term survival in lung transplantation: a Swedish monocentric study. Scand Cardiovasc J. 2020 Oct;54(5):322-329. doi: 10.1080/14017431.2020.1781240. Epub 2020 Jun 23.
- Results publication: PubMed 27052747Fakhro M, Ingemansson R, Skog I, Algotsson L, Hansson L, Koul B, Gustafsson R, Wierup P, Lindstedt S. 25-year follow-up after lung transplantation at Lund University Hospital in Sweden: superior results obtained for patients with cystic fibrosis. Interact Cardiovasc Thorac Surg. 2016 Jul;23(1):65-73. doi: 10.1093/icvts/ivw078. Epub 2016 Apr 6.
- Derived from this study: PubMed 37855706Lindstedt S, Silverborn M, Lannemyr L, Pierre L, Larsson H, Grins E, Hyllen S, Dellgren G, Magnusson J. Design and Rationale of Cytokine Filtration in Lung Transplantation (GLUSorb): Protocol for a Multicenter Clinical Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 13;12:e52553. doi: 10.2196/52553.
- Pre print pre Clinical trailLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Lindstedt, MD, PhD principal investigator
Skånes universitetssjukhus Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb in people with Lung Transplant Failure and Lung Transplant; Complications, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation at 24 hours (time frame: 24 hours after lung transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242289, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.