Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure
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|ClinicalTrials.gov Identifier: NCT00348556|
Recruitment Status : Terminated (Company providing catheter bought out, funding and supplies terminated)
First Posted : July 4, 2006
Results First Posted : October 17, 2012
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiorenal Syndrome||Drug: Nesiritide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Intra-renal Infusion of BNP in Enhancing Renal Function in Human CHF With Cardiorenal Syndrome: A Pilot Study|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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.
Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.
- Change in Glomerular Filtration Rate (GFR) at 24 Hours [ Time Frame: 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.
- Change in Urinary Sodium Excretion at 24 Hours [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348556
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Horng H. Chen, M.D.||Mayo Clinic|