The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of days of mechanical ventilation
研究概览
简要总结
This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.
详细描述
This study will enroll infants undergoing cardiothoracic surgery requiring deep hypothermic circulatory arrest (DHCA) at the University of Michigan's C.S. Mott Children's Hospital. Patients that are eligible will be randomized to receive either one dose surfactant or the sham (air) arm after the surgical procedure. Patients will be monitored for an additional 30 days after the breathing tube is removed. It is possible that subjects may be discharged prior to the last assessment, therefore for subjects who have been discharged a member of the study team will contact the parent (s) or legal authorized representative by telephone.
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
- 1 Day 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients less than or equal to 12 weeks of age with hypoplastic left heart syndrome (HLHS) undergoing cardiothoracic surgical correction (Norwood) requiring DHCA.
- •Infants weighing 2500 grams or greater at the time of surgery.
- •Written informed consent from parent(s) or legally appointed representative (LAR).
排除标准
- •Patients who are less than 36 weeks Post Menstrual Age (PMA) at the time of surgical correction.
- •Underlying craniofacial, airway or lung anomalies which could compromise administration of surfactant.
- •Infants weighing less than 2500 grams at the time of the surgical correction.
- •Mechanical ventilation for> 7 days prior to surgical correction.
研究组 & 干预措施
Curosurf
干预措施: Curosurf (Drug)
Sham (air)
干预措施: Sham (Drug)
结局指标
主要结局
Number of days of mechanical ventilation
时间窗: Throughout hospitalization (approximate average 5 days)
This will be the number of days from intubation to the extubation date.
Number of days in the Pediatric Cardiothoracic Unit
时间窗: Approximately 11 days
From time of admission until transfer out of the unit.
Number of post-operative hospital days
时间窗: Up to 1 year
次要结局
- Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure(Up to 1 year)
- Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation(Approximately 1 week)
- Changes in positive end-expiratory pressures post intervention(Baseline to approximately 1 week)
- Changes in peak inspiratory pressures post intervention(Baseline to approximately 1 week)
- Changes in dynamic lung compliance post intervention(Baseline to approximately 1 week)
- Changes in oxygen requirements post intervention(Baseline to approximately 1 week)
- Changes in oxygenation index (OI) post intervention(Baseline to approximately 1 week)
- Time to successful extubation readiness trials (ERT) post intervention(Approximately 1 week)
- Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation)(Up to 1 year)
研究者
Steven Donn, M.D.
Professor Emeritus of Pediatrics
University of Michigan