Cytokine Adsorption in Lung Transplantation

NCT ID: NCT05242289

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-08-30

Brief 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). 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.

Conditions

Lung Transplant Failure; Lung Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated

Treatment using the medical "cytokine adsorption" device in conjunction with lung transplantation

Group Type: ACTIVE_COMPARATOR

CytoSorb

Intervention Type: DEVICE

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

Non-treated

No additional treatment in conjunction with lung transplantation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CytoSorb

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Double lung transplantation
• Single organ failure

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sandra Lindstedt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Lindstedt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skånes universitetssjukhus Lund

Locations

Skåne University Hospital

Lund, Skåne County, Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 35011653 (View on PubMed)

Ghaidan 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.

Reference Type: RESULT

PMID: 32573283 (View on PubMed)

Fakhro 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.

Reference Type: RESULT

PMID: 27052747 (View on PubMed)

Lindstedt 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.

Reference Type: DERIVED

PMID: 37855706 (View on PubMed)

Related Links

https://www.researchsquare.com/article/rs-220294/v1

Pre print pre Clinical trail

Other Identifiers

LUSorb

Identifier Type: -

Identifier Source: org_study_id