Clinical trial NCT00205426: Natrecor for Pulmonary Hypertension in Lung Transplants
Official title: Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension in lung transplant recipients
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO use by matched historical controls.

Detailed description: A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants. The amount of reperfusion injury varies from person to person. IRI occurs when the blood supply to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can cause a decrease in function in a newly transplanted lung. When this occurs, or when people have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given by inhalation while patients are on a ventilator (breathing machine). Because NO must be given by a ventilator and because patients on ventilators must be in an intensive care unit, the cost of treating people with NO is very high. NO can also cause rebound pulmonary hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension. A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant patients. Doctors believe it may be helpful to lung transplant patients as well.

Eligibility criteria: Inclusion Criteria:

* Single or double lung transplant or heart/lung transplant recipient
* Planned use of Natrecor
* Pulmonary artery (PA) systolic pressures \> 35

Exclusion Criteria:

* Previous lung transplant
* Use of Prolastin after pneumonectomy
* Mean arterial pressure of \< 55
* Known allergy or sensitivity to nesiritide
* Females of childbearing potential with a positive pregnancy test or women who are breast feeding
* Use of nesiritide, for any reason, within 30 days prior to transplant

Primary outcomes:
measure: To evaluate the safety and efficacy of Natrecor® in reducing nitric oxide used perioperatively in patients undergoing single or double lung transplantation who have or are at risk for developing pulmonary hypertension
Secondary outcomes:
measure: To compare total cost-effective evaluation between patients receiving Natrecor and those who received iNO
measure: To compare length of stay in the Intensive Care Unit (ICU)
measure: To compare renal function as defined by peak serum creatinine and calculated creatinine clearance during the first 72 hours post-transplant
measure: To compare necessity of CPB between Natrecor® versus nitric oxide
measure: To compare hemodynamic parameters
measure: To compare length of stay (total)
measure: To compare time to dry weight
measure: To compare duration of mechanical ventilation
measure: To compare pulmonary parameters
measure: To compare IRI via chest x-ray and PAO2/FIO2 ratio
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School
name: Robert Love, MD
role: PRINCIPAL_INVESTIGATOR
References: