Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Prevention of acute kidney injury
研究概览
简要总结
The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.
详细描述
Acute kidney injury (AKI) is a frequent complication immediately after heart transplantation (HT), with incidence rates between 40-70%. Several factors contribute to this complication, such as hypervolemia, hyperactivation of renin-angiotensin-aldosterone system (RASS) and low cardiac output. Hypertonic saline solution (HSS) can reduce diuretic resistance, increase urinary output and improve renal function in hypervolemic status such as acute heart failure. Therefore, the investigators hypothesized that the use of HSS could prevent or attenuate AKI after heart transplantation in the early postoperative phase. The investigators aim to randomize 74 patients to receive 150 mL of HSS 3,5% or placebo (saline solution 0,9%) twice daily for 3 days after HT. Renal function, right ventricular echocardiographic parameters and pulmonary artery catheter parameters will be assessed. Patients will be followed-up until 30 days, or death.
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 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospitalized patients submitted to orthotopic heart transplantation (HT)
排除标准
- •Requirement of renal replacement therapy at the time of HT
- •Requirement of extracorporeal membrane oxygenation (ECMO) before or immediately after HT
- •Severe peri-operative mechanical complications
- •Double transplant (e.g. heart-kidney or heart-lung)
- •Hypernatremia (Na ≥ 145)
- •Severe hyponatremia (Na ≤ 120)
研究组 & 干预措施
Hypertonic Saline Solution 3,5% (HSS)
干预措施: Sodium chloride solution 3,5% (Drug)
Normal Saline Solution (NS)
干预措施: Sodium chloride solution 0,9% (Drug)
结局指标
主要结局
Prevention of acute kidney injury
时间窗: Days 3 -7 post-transplantation
Demonstrate a peak value of creatinine 30% lower in the active arm
次要结局
- Incidence of right ventricular dysfunction(Until day 5 post-transplantation)
- Mortality(30 days)
- Incidence of acute kidney injury requiring hemodialysis(30 days)
- Intensive care unit (ICU) length of stay(During ICU stay, an average of 5 days)
- Time to wean inotropes and vasopressors(During ICU stay, an average of 5 days)
- Hypertonic saline solution (HSS) hemodynamic effect(Until day 3 post-transplantation)
- Difference in loop diuretic efficiency between groups(Days 1 -3 post-transplantation)
研究者
Fernando Bacal
Director of Heart Transplant Unit (Heart Institute).
University of Sao Paulo General Hospital