Natrecor for Pulmonary Hypertension in Lung Transplants

NCT00205426 | Completed Phase 4 DMC

• 1 other identifier: H-2005-0185
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension in lung transplant recipients

Outcome Measures

Primary Outcomes (1)

• 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 (10)

• 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

Study Arms (1)

Natrecor infusion

EXPERIMENTAL

Nesiritide

Drug: Natrecor

Interventions

Natrecor DRUG

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.

Also known as: nesiritide

Natrecor infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Robert Love, MD

  University of Wisconsin Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)