Clinical Trial: Nesiritide and Renal Function After the Total Artificial Heart

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Impact of Nesiritide on Renal Function After Implantation of the Total Artificial Heart and Left Ventricular Assist Devices

Brief Summary: The prevalence of renal dysfunction after implantation of the artificial heart is high. The infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total artificial heart (TAH) improves renal function in a sustained manner. The renal protective and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared to heart failure surgery that leaves the native myocardium intact. The goal of this project is to determine the renal protective effects of nesiritide after implantation of a mechanical device.

Detailed Summary:

This is a randomized, double blinded placebo controlled study that will take place in the Cardiac Surgery Intensive Care Unit, at Virginia Commonwealth University (VCU) Hospital Center.

This study will enroll 20 adult patients who have undergone implantation of a circulatory support device (10 TAH patients, 10 Left ventricular assist device (LVAD) patients). Patients will receive standard postoperative care, including anticoagulation, continuous hemodynamic monitoring with an arterial line and central venous line and hemodynamic support as determine by the cardiac surgery clinical team. We will exclude patients who are receiving renal replacement therapy at the time of device implantation or those that have had previous solid organ transplantation in order to remove the confounding influence of calcineurin inhibitor exposure on renal function. Patient unable to provide informed consent will also be excluded.

Nesiritide Infusion

The patients will be randomized (stratified by device type) to either the study drug (nesiritide at 0.005 mcg/kg/min without a bolus) or placebo. A fixed-dose infusion will be initiated 6 hours after the patients having come off of cardiopulmonary bypass and continued for 48 hours.

Laboratory Measurements

Acute and chronic effects of nesiritide on Glomerular Filtration Rate (GFR) and Renal Plasma Flow (RPF) will be measured by continuous infusion of iothalamate (IOTH) and phenylalanine hydroxylase (PAH), respectively. GFR and RPF will be measured at baseline (-3 to 0 hrs) and at 3 intervals during drug/placebo administration as follows: 0 to 6, 6 to 16 and 16 to 40. Intravenous catheters will be placed as needed for infusion of PAH and IOTH and for tim
Sponsor: Virginia Commonwealth University

Current Primary Outcome:

  • Glomerular Filtration Rate [ Time Frame: 46 hours ]
  • Renal Plasma Flow [ Time Frame: 46 Hours ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for Hemodialysis/Renal Replacement Therapy [ Time Frame: 90 days ]
  • Urine Output [ Time Frame: 46 Hours ]
  • Time to Renal Failure [ Time Frame: 46 Hours ]
  • Total Diuretic Requirement [ Time Frame: 46 Hours ]


Original Secondary Outcome:

  • Need for hemodialysis [ Time Frame: 90 days ]
  • Urine Output [ Time Frame: 46 Hours ]


Information By: Virginia Commonwealth University

Dates:
Date Received: April 17, 2013
Date Started: April 2013
Date Completion:
Last Updated: January 13, 2016
Last Verified: January 2016