Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Chest Tube Drainage
研究概览
简要总结
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
详细描述
A pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.
Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients will be enrolled with five patients as control group and five receiving Vasopressin. Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours later in the pilot study. Safety and effect size will be evaluated after this pilot study.
Drug administration protocol:
Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug drip will infuse for 48 hours after which will be discontinued.
The placebo group will be receiving normal saline at the same rate of the vasopressin group. The treating physician will be blinded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 1.5-7 years old undergoing Fontan operation.
排除标准
- •Patients with a planned fenestrated Fontan.
- •Patients undergoing revision surgery for failing Fontan.
- •Evidence of renal insufficiency prior to surgery defined by creatinine >1 mg/dl.
- •Planned arch reconstruction at the time of the Fontan procedure
研究组 & 干预措施
Vasopressin
Vasopressin at 0.4mU/kg/min
干预措施: Vasopressin (Drug)
Normal saline
Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Chest Tube Drainage
时间窗: From post operative day 0 through study completion, an average of 1 month
chest tube drainage until the day the chest tube is removed
次要结局
- Length of Hospital Stay(From the day of the surgery (post operative day 0) through study completion, an average of 1 month)