Renal Effects of Intrarenal Nesiritide

Status Terminated

Clinical Trial Summary

The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation leads to adverse consequences even if the direct renal effects are positive. Therefore, this study will look at the effects of direct intrarenal administration of nesiritide on GFR and RPF.

Clinical Trial Description

We will perform an open-label, parallel arm, controlled study of intrarenal nesiritide in 26 patients hospitalized with CHF. Patients will be admitted for CHF exacerbation and randomly but equally divided into treatment and placebo groups. Both arms will receive diuretics on admission as dictated by clinical need. They will then have an 8-hour diuretic-free period (overnight). Each arm will then have renal parameters (GFR, RPF, urine output, urinary sodium excretion) assessed using PAH and iothalamate. These parameters will be measured prior to administration of drug during period 1. Randomization will be performed via an interactive computerized call in program following completion of screening procedures and once patient has given informed consent.

At time 0, treatment patients will be taken to the cardiac catheterization lab for placement of the Benephit Infusion System (Flow Medica). Placement involves femoral artery cannulation and introduction of a bifurcated infusion catheter into the arterial system to a destination at the level of renal arteries. This will be done under fluoroscopic guidance.

When placement of catheter is completed, period 2 will begin with initiation of Study Drug infusion (IR nesiritide or IV D5W). Nesiritide will be diluted according to its labeled instructions in D5W to a final dilution of 6 mcg/mL. Placebo patients will receive IV D5W as a bolus and a continuous infusion of D5W at volumes equal to what they would have gotten had they been randomized to nesiritide.

Intra-renal (IR) infusion of nesiritide will be given as a 2ug/kg bolus followed by an infusion of 0.01 mg/kg/min through the intrarenal catheter. The nesiritide infusion will continue for 6 hours.

Period 3 begins at the 3-hour mark, at which time, both the placebo and treatment groups will be treated with boluses of intravenous furosemide. Both treatment arms will receive furosemide at this time. Blood drawn at 3 and 6 hours and urine collected between 3 and 6 hours will be used to determine GFR, RPF, Na excretion and urine output. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00270829
Study type	Interventional
Source	University of Maryland, Baltimore
Contact
Status	Terminated
Phase	Phase 4
Start date	December 2005
Completion date	January 2007

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.