Lung Transplant; Complications
Conditions
Brief summary
The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung 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 receive one dose of the study drug, Etanercept, via subcutaneous injection just prior to the lung transplant. Patients randomized to the control group will not receive Etanercept. Both groups will receive standard lung transplant care after implantation.
Interventions
DRUGEtanercept Injection [Enbrel]
25 mg subcutaneous injection
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planning to undergo transplantation of the lung at Northwestern Memorial Hospital. * Willing and able to read, understand, and be capable of giving informed consent.
Exclusion criteria
* Previous or current use of TNFa antibody. * Positive virtual or retrospective crossmatch or highly sensitized (pRA \> 30%) recipients. * Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of kidney dysfunction immediately after lung transplant | Immediately after lung transplant | Measured by serum creatinine blood tests |
| Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant | Within 1-7 days after lung transplant | Measured by serum creatinine blood tests |
| Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant | Up to 30 days after lung transplant | Measured by serum creatinine blood tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of primary graft dysfunction | Within 3 days post-transplant | Measured by arterial blood gas (ABG) blood tests and chest X-rays |
| Length of intensive care unit (ICU) stay | Through study completion, an average of 1 year | Measured by number of days in the ICU post-transplant |
| Length of ventilator use | Through study completion, an average of 1 year | Measured by number of days on a ventilator post-transplant |
| Survival | 30 days, 90 days, and one year survival post-transplant | Alive or dead post-transplant |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChitaru Kurihara, MD
Northwestern University
Outcome results
None listed