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临床试验/NCT03946462
NCT03946462撤回1 期

A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery

Fabio Savorgnan1 个研究点 分布在 1 个国家开始时间: 2021年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
发起方
试验地点
1
主要终点
NGAL level

研究概览

简要总结

This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas

详细描述

Screening: All patients undergoing either elective or emergency cardiac surgery will be screened against the eligibility criteria.

Research Sample Collection: Blood and urine will be collected for the first 48 hours admission and analyzed. The specific time points for these parameters will be: 2 hours, 6 hours, 12 hours 24 hours, and 48 hours post admission. Blood and urine parameters will also be collected as a baseline pre-operative. Patient outcomes will be captured for 30 days post operatively.

Research Data Collection: Baseline information will be collected. Other research related variables collected during the surgical intervention and bypass. Additional information will be collected 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after admission as well as outcomes 30 days after the procedure.

Participants will be randomly allocated to the NO or control group in a 1:1 ratio.

This study is investigating a possible protective role for NO gas administration during bypass on the subsequent development of AKI. NO is typically delivered via large, stand-alone cylinders that are placed at the bedside (or adjacent to the patient) and is set up by respiratory therapists. In this research study, the study gas (NO or placebo) will be delivered directly into the bypass circuit at a constant gas flow. The placebo gas in this study will be 21% (or atmospheric) oxygen, and will appear to all members of the clinical and research teams (with the exception of the respiratory therapist responsible for setting it up) indistinguishable from NO, rendering this a double-blind study for the patient (or caregiver) and the investigators. This minimizes any possibility of bias in the study.

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
Double (Participant, Investigator)

盲法说明

subjects, caregivers and research team members are blinded while respiratory therapists are unblinded

入排标准

年龄范围
— 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Age: </= 30 days
  • Gestational age: 38 weeks
  • Diagnosis: Congenital Heart Disease (CHD)
  • Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD
  • Consent of parent/guardian

排除标准

  • Currently receiving or has received inhaled nitric oxide (NO) or other nitrogen donors such as sildenafil or nitroprusside
  • Pre-existing acute kidney injury (AKI) as per the AKIN criteria;
  • Cardiac arrest within one week prior consent;
  • Prior cardiac surgery with CPB procedure;
  • Prior history of Extra Corporeal Membrane Oxygenation (ECMO)
  • Use of another investigational drug.

研究组 & 干预措施

NO Group

Experimental

干预措施: NO gas delivered during cardiac surgery (Drug)

Placebo Group

Placebo Comparator

干预措施: placebo gas delivered during cardiac surgery (Other)

结局指标

主要结局

NGAL level

时间窗: 48 hours

1 of 2 biomarkers to determine acute kidney injury (AKI)

Cystatin-C level

时间窗: 48 hours

2 of 2 biomarkers to determine acute kidney injury (AKI)

次要结局

未报告次要终点

研究者

发起方
Fabio Savorgnan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fabio Savorgnan

Principal Investigator / Assistant Professor

Baylor College of Medicine

研究点 (1)

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