Lung Transplant FailureNCT05526950
Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)
A study testing Device: 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 80 years
- Conditions the study is for
- Lung Transplant Failure, Lung Transplant; Complications
- What is being tested?
- Device: CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSweden
- Study dates
- 7 Sep 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility to undergo double lung transplantation at either trial site
Who cannot join
- Age <18 years
- Previous organ transplantation
- Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:
- Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation.
- Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation.
- Non-consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jesper Magnusson, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Sandra Lindstedt
Lund, Skåne County, 224 60
Sandra Lindstedt, +46737220580, sandra.lindstedt.ingemansson@gmail.com
Jesper Magnusson, MD, PhD
About this study
Official title: Cytokine Filtration in Lung Transplantation - a Randomised, Controlled, Multicentre Clinical Trial (GLUSorb)
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.
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 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
- Device: CytoSorb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: 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: 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.
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation.
Higest value of oxygenation expressed as the PaO2/FiO2 ratio.
Measured: First 72 hours after lung transplantation
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 24 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours
Measured: 24 hours after lung transplantation
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 48 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours
Measured: 48 hours after lung transplantation
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. Oxygenation at 72 hours
Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
Measured: 72 hours after lung transplantation
Secondary outcomes (14)
To determine whether cytokine reduction by cytokine filtration improves levels of plasma inflammatory markers (including cytokines) in patients undergoing lung transplantation.
Plasma levels of inflammatory markers: interleukin (IL)-10, IL-1β, soluble IL-2 receptor, IL-6, IL-8, and tumour necrosis factor (TNF)α before and immediately after transplantation and at 6, 12, 24, 48, and 72 hours after transplantation, and C-reactive protein (CRP) and white blood cells before and immediately after transplantation and at day 1, 2, and 3 after transplantation
Measured: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases lung infiltrates and oedema in patients undergoing lung transplantation
Infiltrates and oedema measured by chest x-ray and/or CT scan of the thorax at day 1, 2, and 3 after transplantation
Measured: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration improves arterial blood gas measures in patients undergoing lung transplantation
Highest daily arterial blood gas measurements recorded on day 1, 2, and 3 after transplantation, as a measure of lung function
Measured: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases severity of primary graft dysfunction (PGD) in patients undergoing lung transplantation
PGD severity as evaluated per standard clinical procedures using a rating scale from 0-3 on day 1, 2, and 3 after transplantation, as a measure of lung function
Measured: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases incidence of primary graft dysfunction (PGD) in patients undergoing lung transplantation
Presence of any grade of PGD on day 1, 2, and 3 after transplantation, as a measure of lung function
Measured: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases need for norepinephrine in patients undergoing lung transplantation
Total dose of norepinephrine administered in the first 72 h
Measured: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases mortality in patients undergoing lung transplantation
Mortality up to 48 months after transplantation
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves diffusion capacity of the lungs (DLCO) in patients undergoing lung transplantation
Lung diffusion capacity, measured by carbon monoxide (CO) diffusion, at 6, 12, 24, and 48 months after transplantation, as a measure of lung function
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves forced expiratory volume (FEV1), forced vital capacity (FVC), and total lung capacity in patients undergoing lung transplantation
Forced expiratory volume (FEV1), forced vital capacity (FVC), and total lung capacity (TLC) measured by spirometry at 1, 3, 6, 12, 24 and 48 months after transplantation, as a measure of lung function
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves occurrence of any acute rejection episodes in patients undergoing lung transplantation
Occurrence of any acute rejection episodes (clinically treated and/or biopsy verified) up to 48 months after transplantation, as a measure of lung function
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves Chest CT in patients undergoing lung transplantation
Chest CT findings at 1, 3, 6, 12, 24, 36 and 48 months after transplantation
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves presence of any CLAD in patients undergoing lung transplantation
Presence of any CLAD and CLAD subtypes up to 48 months after transplantation, as a measure of lung function
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves kidney function in patients undergoing lung transplantation
Kidney function evaluated by measurement of serum creatinine levels; calculated glomerular filtration rate (GFR); and need for renal replacement therapy on day 1, 2, and 3 and at 1, 3, 6, 9, 12, 24, and 48 months after transplantation; urea levels on day 1, 2, and 3 after transplantation; and iohexol clearance at 3, 6, 9, 12, 24, 36, and 48 months after transplantation
Measured: First 4 years
To determine whether cytokine reduction by cytokine filtration improves quality of life (QOL) in patients undergoing lung transplantation
QOL evaluated by the 36-Item Short Form Health Survey (SF-36) at 24 and 48 months after transplantation
Measured: First 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start7 Sep 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 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
- 116 participants (estimated)
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
- NCT05526950
- Sponsor's protocol ID
- GLUSorb
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results will be presented at group level. No individual data.
Publications
Ghaidan H, Stenlo M, Niroomand A, Mittendorfer M, Hirdman G, Gvazava N, Edstrom D, Silva IAN, Broberg E, Hallgren O, Olm F, Wagner DE, Pierre L, Hyllen S, Lindstedt S. Reduction of primary graft dysfunction using cytokine adsorption during organ preservation and after lung transplantation. Nat Commun. 2022 Jul 26;13(1):4173. doi: 10.1038/s41467-022-31811-5.
PubMed 35882835Niroomand A, Qvarnstrom S, Stenlo M, Malmsjo M, Ingemansson R, Hyllen S, Lindstedt S. The role of mechanical ventilation in primary graft dysfunction in the postoperative lung transplant recipient: A single center study and literature review. Acta Anaesthesiol Scand. 2022 Apr;66(4):483-496. doi: 10.1111/aas.14025. Epub 2022 Jan 27.
PubMed 35014027Niroomand 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 35011653Lindstedt S, Niroomand A, Mittendorfer M, Hirdman G, Hyllen S, Pierre L, Olm F. Nothing but NETs: Cytokine adsorption correlates with lower circulating nucleosomes and is associated with decreased primary graft dysfunction. J Heart Lung Transplant. 2023 Oct;42(10):1358-1362. doi: 10.1016/j.healun.2023.06.011. Epub 2023 Jun 20.
PubMed 37348689Lindstedt 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 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Filtration in Lung Transplantation - a Randomised, Controlled, Multicentre Clinical Trial (GLUSorb)
- ClinicalTrials.gov ID
- NCT05526950
- Acronym / sponsor ID
- GLUSorb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Sep 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. 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.
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 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 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: 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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligibility to undergo double lung transplantation at either trial site
Key exclusion criteria (6 listed)
- Age <18 years
- Previous organ transplantation
- Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:
- Non-consent
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 |
|---|---|---|
| Device: CytoSorbMedical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation. | Device | Treated |
Primary outcome
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 72 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
14 secondary outcomes
To determine whether cytokine reduction by cytokine filtration improves levels of plasma inflammatory markers (including cytokines) in patients undergoing lung transplantation.
Time frame: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases lung infiltrates and oedema in patients undergoing lung transplantation
Time frame: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration improves arterial blood gas measures in patients undergoing lung transplantation
Time frame: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases severity of primary graft dysfunction (PGD) in patients undergoing lung transplantation
Time frame: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases incidence of primary graft dysfunction (PGD) in patients undergoing lung transplantation
Time frame: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases need for norepinephrine in patients undergoing lung transplantation
Time frame: 0-72 hours (0-3 days) after lung transplantation
To determine whether cytokine reduction by cytokine filtration decreases mortality in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves diffusion capacity of the lungs (DLCO) in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves forced expiratory volume (FEV1), forced vital capacity (FVC), and total lung capacity in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves occurrence of any acute rejection episodes in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves Chest CT in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves presence of any CLAD in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves kidney function in patients undergoing lung transplantation
Time frame: First 4 years
To determine whether cytokine reduction by cytokine filtration improves quality of life (QOL) in patients undergoing lung transplantation
Time frame: First 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 35882835Ghaidan H, Stenlo M, Niroomand A, Mittendorfer M, Hirdman G, Gvazava N, Edstrom D, Silva IAN, Broberg E, Hallgren O, Olm F, Wagner DE, Pierre L, Hyllen S, Lindstedt S. Reduction of primary graft dysfunction using cytokine adsorption during organ preservation and after lung transplantation. Nat Commun. 2022 Jul 26;13(1):4173. doi: 10.1038/s41467-022-31811-5.
- Background: PubMed 35014027Niroomand A, Qvarnstrom S, Stenlo M, Malmsjo M, Ingemansson R, Hyllen S, Lindstedt S. The role of mechanical ventilation in primary graft dysfunction in the postoperative lung transplant recipient: A single center study and literature review. Acta Anaesthesiol Scand. 2022 Apr;66(4):483-496. doi: 10.1111/aas.14025. Epub 2022 Jan 27.
- Background: 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.
- Background: PubMed 37348689Lindstedt S, Niroomand A, Mittendorfer M, Hirdman G, Hyllen S, Pierre L, Olm F. Nothing but NETs: Cytokine adsorption correlates with lower circulating nucleosomes and is associated with decreased primary graft dysfunction. J Heart Lung Transplant. 2023 Oct;42(10):1358-1362. doi: 10.1016/j.healun.2023.06.011. Epub 2023 Jun 20.
- 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.
- Individual participant dataSharing planned: No. All results will be presented at group level. No individual data.
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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.
Jesper Magnusson, MD, PhD contact
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 Device: 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Lindstedt, MD,PhD (+46737220580, sandra.lindstedt_ingemansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether cytokine reduction by cytokine filtration leads to improved oxygenation in patients undergoing lung transplantation. (time frame: First 72 hours after lung transplantation). The study lists 4 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 NCT05526950, which also lists 5 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 18 Sep 2023.