NCT00559338

Impact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department

Acutely Decompensated Heart Failure in a County Emergency Department: A Double Blind Randomized Controlled Comparison of Nesiritide vs. Placebo Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if an 8hr infusion of nesiritide in the emergency department in the Acutely decompensated heart failure patients will decrease 30 day recidivism.

Detailed description

In view of the high return admission rate to our county ED for heart failure, we hypothesized that our higher risk patient population might realize a decrease in the return admission rate as a benefit from early ED administration of nesiritide. We also acknowledged that the safety of nesiritide in our patient population had not been well established. Thus, we opted to test the hypothesis that an 8-hour ED infusion of nesiritide \[in addition to protocol specified standard therapy\] in ADHF patients from an urban patient population consisting of predominately African Americans and Hispanics will decrease 30-day readmission rates without provoking harm.

Conditions

• Heart Failure, Congestive
• Cardiomyopathy

Interventions

Type	Name	Description
DRUG	recombinant B-type, natriuretic peptide	The intravenous infusion of nesiritide consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The nesiritide was mixed in 250 ml of 0.9% normal saline solution.
DRUG	placebo	The intravenous infusion of placebo consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The placebo was mixed in 250 ml of 0.9% normal saline solution.

Timeline

• Start date: 2003-12-01
• Completion: 2005-04-01
• First posted: 2007-11-16
• Last updated: 2007-11-16

Locations

1 site across 1 country: United States