Viewing Study NCT01715883



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Last Modification Date: 2024-10-26 @ 10:58 AM
Study NCT ID: NCT01715883
Status: TERMINATED
Last Update Posted: 2018-08-01
First Post: 2012-10-08

Brief Title: Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction
Sponsor: Gladwin Mark MD
Organization: University of Pittsburgh

Study Overview

Official Title: Sodium Nitrite Administration at the Time of Lung Organ Procurement and Transplantation to Minimize the Risk of Pulmonary Graft Dysfunction
Status: TERMINATED
Status Verified Date: 2018-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Lack of support staff
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a Phase 2 observational nonrandomized pilot investigation to evaluate the safety and efficacy of Sodium Nitrite administration for the reduction of Primary Graft Dysfunction PGD in patients undergoing lung transplant The study will enroll 8 subjects undergoing lung transplant at the University of Pittsburgh Medical Center UPMC
Detailed Description: While increasing numbers of patients with advanced lung disease are candidates for lung transplantation the short- and long-term outcomes are severely compromised by graft dysfunction primarily in the form of organ rejection The earliest manifestation of lung allograft dysfunction termed primary graft dysfunction PGD represents a form of ischemia-reperfusion acute lung injury and occurs in its severest form Grade 3 in from 10 to 35 of lung transplant recipients 1-6 PGD is the primary cause of early morbidity and mortality after transplantation and is strongly associated with the late development of chronic lung rejection or Bronchiolitis Obliterans Syndrome BOS Early graft dysfunction contributes significantly to the suboptimal outcomes of lung transplantation and to the failure of lung transplant recipients to achieve five-year survival rates comparable to patients who receive other solid organs such as the heart and liver The risk of PGD further limits the time that lungs can be stored ex-vivo therefore restricting the pool of available donors A critical advance in the prevention of both early and late lung allograft dysfunction will occur if PGD can be successfully prevented or minimized

In this study the investigators propose to test the hypothesis that administration of Sodium Nitrite to donor lungs and lung transplant recipients at the time of transplantation will be safe and will reduce the incidence of grades 2 and 3 PGD thereby improving clinical outcomes with minimal toxicity

Sodium Nitrite will be obtained from a commercial preparation Hope Pharmaceuticals and the UPMC Pharmacy will prepare the formulations which will be infused at three time points First it will be infused into the preservation solution bag at the time of organ procurement from the donor then to the allograft at the time of transplantation and finally as a direct infusion into the organ recipient

The investigators plan to enroll total of 8 subjects undergoing lung transplantation for this Phase 2 observational non-randomized pilot investigation to evaluate the safety efficacy and pharmacokinetics of Sodium Nitrite administration when administered to the procured lung and lung transplant recipient for the prevention of Primary Graft Dysfunction PGD It is anticipated that positive results from this trial lead to a larger clinical investigation of Sodium Nitrite administration directed at producing a reduction in PGD and perhaps secondary obliterative bronchiolitis and will potentially allow for extended organ storage extended use of more marginal organs and more effective use of Donation after Cardiac Death DCD organs which undergo combination of warm and cold ischemia for organ procurement

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None