Natrecor for Pulmonary Hypertension in Lung Transplants

Pulmonary Hypertension Clinical Trial

Official title:

Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205426
• Other study ID #: H-2005-0185
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 13, 2015
• Start date: August 2005
• Est. completion date: May 2006

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Natrecor
Natrecor will be initiated as a bolus dose of 2 mcg/kg followed by a continuous infusion via infusion pump after induction of anesthesia but prior to incision. Natrecor infusion will be started at the recommended rate of 0.01mcg/kg/min. This dose may be adjusted by the investigator(s) only based on hemodynamic monitoring and pulmonary parameters. Study drug will be infused for a minimum of 24 hours and a maximum of 96 hours.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare total cost-effective evaluation between patients receiving Natrecor and those who received iNO
Secondary	To compare length of stay in the Intensive Care Unit (ICU)
Secondary	To compare renal function as defined by peak serum creatinine and calculated creatinine clearance during the first 72 hours post-transplant
Secondary	To compare necessity of CPB between Natrecor® versus nitric oxide
Secondary	To compare hemodynamic parameters
Secondary	To compare length of stay (total)
Secondary	To compare time to dry weight
Secondary	To compare duration of mechanical ventilation
Secondary	To compare pulmonary parameters
Secondary	To compare IRI via chest x-ray and PAO2/FIO2 ratio