Lung Transplant Recipient
Conditions
Keywords
lung transplant
Brief summary
This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). In this study, lung transplant participants who are randomized to the treatment group will have the study drug injected into the solution that their donor lungs are kept in prior to transplant.
Detailed description
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will have one dose of the study drug, Anakinra, injected into the perfusion solution that their donor lungs are kept in just prior to lung transplant. Both groups will receive standard lung transplant care after implantation.
Interventions
DRUGAnakinra
100 mg injection
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Planning to undergo transplantation of the lung. * Willing and able to read, understand, and be capable of giving informed consent. * Use of ex vivo lung perfusion (EVLP) prior to lung transplant.
Exclusion criteria
* Previous or current use of IL-1R antagonist drug. * Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating, such as highly sensitized patients who require additional immunosuppression, multiorgan transplant, and re- transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary graft dysfunction after lung transplant | 3 days post lung transplant | Occurrence of primary graft dysfunction after lung transplant on post-operative day 3, measured by arterial blood gas blood tests and chest X-rays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay post lung transplant, assessed up to one year post transplant | Days post lung transplant up to 52 weeks | Length of intensive care unit stay post lung transplant |
| Length of hospital stay post lung transplant, assessed up to one year post transplant | Days post lung transplant up to 52 weeks | Length of hospital stay post lung transplant |
| Length of ventilator use post lung transplant, assessed up to one year post transplant | Days post lung transplant up to 52 weeks | Length of ventilator use post lung transplant |
| Survival after lung transplant | 30 days, 90 days and one year post lung transplant | 30 days, 90 days, and one year survival status after lung transplant |
Countries
United States
Contacts
CONTACTMary Carns, MS
PRINCIPAL_INVESTIGATORChitaru Kurihara, MD
Northwestern University
Outcome results
None listed