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临床试验/NCT01836809
NCT01836809终止4 期

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

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
2
试验地点
1
主要终点
Glomerular Filtration Rate

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Implanted with a total artificial heart (CardioWest) or Left ventricular assist device (HeartMate II)
  • Age > 18 years

排除标准

  • Previous calcineurin inhibitor (CNI) exposure
  • Hemodialysis prior to device implant

研究组 & 干预措施

LVAD: Placebo

Placebo Comparator

Control arm for subjects receiving LVAD and randomized to placebo

干预措施: placebo (Drug)

Total Artificial Heart

Experimental

Nesiritide

干预措施: nesiritide (Drug)

Total Artificial Heart: Placebo

Placebo Comparator

Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo

干预措施: placebo (Drug)

LVAD: Nesiritide

Active Comparator

Active arm of the LVAD group

干预措施: nesiritide (Drug)

结局指标

主要结局

Glomerular Filtration Rate

时间窗: 46 hours

Renal Plasma Flow

时间窗: 46 Hours

次要结局

  • Need for Hemodialysis/Renal Replacement Therapy(90 days)
  • Urine Output(46 Hours)
  • Time to Renal Failure(46 Hours)
  • Total Diuretic Requirement(46 Hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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