Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Measure Neutrophils to Measure Kidney Injury
研究概览
简要总结
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
详细描述
This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery
- •Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular Filtration Rate) 30-90 ml/min.
- •Signed Informed Consent
排除标准
- •Age <18 or >80
- •Ejection Fraction <30%.
- •Presence of endocarditis or other infection.
- •Presence or anticipated use of an intra-aortic balloon pump.
- •History of an organ transplant.
- •History of an adverse reaction to nesiritide.
- •Surgery performed without cardiopulmonary bypass.
- •Receiving Aprotinin
- •Dopamine administered in doses <5 mcg /kg min.
- •Women of child bearing potential or pregnant or breastfeeding.
- •Participation in any other investigational trial
- •Jehovah Witness
- •Bleeding Disorder
- •Active Endocarditis
研究组 & 干预措施
Nesiritide
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
干预措施: Nesiritide (Drug)
Placebo
infuses at 0.01MCG/KG/min for 48 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Measure Neutrophils to Measure Kidney Injury
时间窗: 30 days from the start of infusion
0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.
The Examine and Measure Cytokines to Measure Kidney Injury
时间窗: 30 days from the start of infusion
Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.
The Examine and Measure Endothelin-1 to Measure Kidney Injury
时间窗: 30 days from the start of infusion
Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.
The Examine and Measure Urinary NGAL to Measure Kidney Injury
时间窗: A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.
Urinary NGAL,a biomarker for kidney injury was measured.
次要结局
未报告次要终点