Natrecor for Pulmonary Hypertension in Lung Transplants

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205426
First received: September 13, 2005
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Drug: Natrecor
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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

Enrollment: 7
Study Start Date: August 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natrecor infusion
Nesiritide
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.
Other Name: nesiritide

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205426

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Robert Love, MD University of Wisconsin Medical School
  More Information

No publications provided

Responsible Party: Cassandra Nunez, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00205426     History of Changes
Other Study ID Numbers: 2005-0185
Study First Received: September 13, 2005
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Pulmonary hypertension in lung transplant recipients

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014