Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure

Phase 1

Terminated

• Conditions: Cardiorenal Syndrome
• Interventions: Drug: Nesiritide

• Registration Number: NCT00348556
• Lead Sponsor: Horng Chen

Brief Summary

The objective of this study is to determine the safety and effectiveness of intrarenal administration of brain natriuretic peptide (BNP) in improving renal function as measured by glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute congestive heart failure (CHF) and deterioration of kidney function (cardiorenal syndrome).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-07-03
• Study First Posted: 2006-07-04
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-09-14
• Results First Posted: 2012-10-17
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nesiritide	Nesiritide	Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.

Primary Outcome Measures

Name	Time	Method
Change in Glomerular Filtration Rate (GFR) at 24 Hours	baseline, 24 hours after start of infusion	Kidney function was to be measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m\^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m\^2 of body surface area is considered to be impaired kidney function.

Secondary Outcome Measures

Name	Time	Method
Change in Urinary Sodium Excretion at 24 Hours	baseline, 24 hours after start of infusion	The fractional excretion of sodium (FENa) measures the percent of filtered sodium that is excreted in the urine. This calculation is widely used to help differentiate prerenal disease (decreased renal perfusion) from acute tubular necrosis (ATN) as the cause of acute kidney injury (AKI, formerly called acute renal failure).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States