Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gladwin, Mark, MD; University of Pittsburgh

Criteria

Inclusion Criteria:

• Subjects undergoing lung transplantation.

• Subjects in the age range of 18-70 years

• Ability to understand and provide consent. Proxy consent will not be accepted.

Exclusion Criteria:

• Donor exclusion criteria

• Age > 55 years.

• Mechanical ventilation > 5 days prior to procurement

• Significant chest trauma or lung contusion

• Smoking history > 20 pack-year

• Ratio of arterial oxygen partial pressure to fractional inspired oxygen < 300

• Donor radiograph with 2 quadrant infiltrates

• Donor that are determined single lung donors prior to transplant will be excluded.

Recipient exclusion criteria

• Recipient age > 70 years.

• Recipient history of pulmonary hypertension (idiopathic pulmonary arterial hypertension, or secondary pulmonary arterial hypertension with mean arterial pressure > 30 mm Hg)

• Recipient history of abnormal cardiac function defined as prior coronary artery bypass graft (CABG) or left ventricular ejection fraction (LVEF) < 45 %

• Recipient history of open thoracotomy/prior pleurodesis as exclusion criteria. However patients who have had limited video-assisted thoracic surgery procedures for biopsies would NOT be excluded from the study.

• Recipient history of cirrhosis

• Recipient history of mechanical ventilation or extracorporeal support pre-operatively

• Recipient pre-operative hypotension defined by a systolic blood pressure less than 90 mm Hg not responsive to intravenous fluids or requirement for vasoactive medications

• Recipient preoperative history of renal insufficiency, dialysis or estimated glomerular filtration rate <30 ml/min/1.73 m2 body surface area

• Patients undergoing retransplantation

• Recipient history of significant coronary artery disease that is flow limiting and unable to be corrected by further percutaneous coronary artery interventions.