Cytokine Adsorption in Lung Transplantation

NCT05242289 | Completed DMC

• 1 other identifier: LUSorb
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Failure; Lung Transplant; Complications

Outcome Measures

Primary Outcomes (3)

• Oxygenation at 24 hours

  Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours

  24 hours after lung transplantation

• Oxygenation at 48 hours

  Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours

  48 hours after lung transplantation

• Oxygenation at 72 hours

  Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours

  72 hours after lung transplantation

Secondary Outcomes (9)

• Diffusion capacity of the lungs (DLCO)

  3 months after transplantation

• Primary Graft dysfunction after 24 hours

  24 hours after lung transplantation

• Primary Graft dysfunction after 48 hours

  48 hours after lungtransplantation

• Primary Graft dysfunction after 72 hours

  72 hours after lungtransplantation

• Urinary output as a measure of kidney function

  First 3 months

Study Arms (2)

Treated

ACTIVE COMPARATOR

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

Device: CytoSorb

Non-treated

NO INTERVENTION

No additional treatment in conjunction with lung transplantation

Interventions

CytoSorb DEVICE

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

Treated

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Double lung transplantation
• Single organ failure

You may not qualify if:

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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Skåne University Hospital

Lund, Skåne County, 224 60, Sweden

Location

Related Publications (4)

• 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.

  PMID: 35011653 RESULT

• 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.

  PMID: 32573283 RESULT

• 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.

  PMID: 27052747 RESULT

• 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.

  PMID: 37855706 DERIVED

Related Links

• Pre print pre Clinical trail

Study Officials

• Sandra Lindstedt, MD, PhD

  Skånes universitetssjukhus Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 16, 2022
• Study Start: March 2, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

SE (1)