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临床试验/NCT01215240
NCT01215240已完成不适用

Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure

University of Alberta2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2010年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Time to First Post-operative Negative 24 Hour Fluid Balance

研究概览

简要总结

Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer.

Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.

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
None

入排标准

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

入选标准

  • Infants with HLHS or its variants who have a Norwood procedure
  • Parental consent

排除标准

  • Premature neonates less than 37 weeks gestation
  • Weight less than 2 kg
  • Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood
  • Pre-operative renal replacement therapy
  • Abdominal defects precluding placement of a PD catheter
  • Known chromosomal abnormality
  • Pre-operative cardiopulmonary resuscitation (CPR)
  • Pre-operative extra-corporeal life support (ECLS)

研究组 & 干预措施

Prophylactic peritoneal dialysis

Experimental

Prophylactic peritoneal dialysis

干预措施: Peritoneal dialysis (Device)

Standard care without PDC

No Intervention

结局指标

主要结局

Time to First Post-operative Negative 24 Hour Fluid Balance

时间窗: up to 72 hours

Time to first post-operative negative fluid balance which occurred in first 72 hrs

次要结局

  • Hospital Length of Stay(Assessed up to 8 weeks)
  • Time to Sternal Closure(Up to 200 hours)
  • Time to Lactate Less Than or Equal to 2mmol/L(From time of admission in PICU until assessment was reached, assessed up to 24 hours)
  • Time to First Extubation(Up to 15 days)
  • Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5(Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsay Ryerson

Clinical assistant professor

University of Alberta

研究点 (2)

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