Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- total cumulative amount of fluids infused
研究概览
简要总结
Background: Volume replacement strategies and type of fluid used in patients undergoing cardiac surgery have changed during the last years. Currently used crystalloid solutes have a variable composition and a major impact on organ function and outcome. Additionally critically ill patients are prone to fluid overload, which is despite common perception, not a benign occurrence as it is associated with prolonged ICU- and hospital length of stay and increased mortality rates. Fluid resuscitation using bolus or continuous infusion of hypertonic saline was used for more than thirty years. Only a few studies have been conducted so far, but they showed that infusion of hypertonic saline results in less volume administered, increased renal function less weight gain in critically ill patients when compared to other crystalloids.
Aim: This preliminary randomized controlled double-blind study aims to identify whether fluid resuscitation using hypertonic saline (HS) when used in addition to lactated Ringers solution results in less total fluid amount administered in patients following cardiac surgery. Additionally we want to evaluate whether the use of hypertonic saline results less need for pharmacological cardiocirculatory support, increased renal function, less postoperative volume overload shortened post-cardiac bypass immune suppression and increased postoperative outcomes.
Study intervention: At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl or 0.9% NaCl by infusion pump over 60 minutes. If necessary, fluid resuscitation will thereafter be performed with Ringer's lactate to normalize peripheral perfusion and to allow weaning of vasopressors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing cardiac surgery for ischemic or valvular heart disease
排除标准
- •Patients unable to give informed consent
- •Patients with age <18 years
- •Pregnancy or breastfeeding
- •Left-ventricular ejection fraction (LVEF) < 30% preoperatively
- •Preexisting renal insufficiency with an eGFR <30 ml/min/1.73m2
- •Patients with postoperative circulatory support devices such as LVAD, IABP, Impella, ECMO
- •Preexisting serum sodium of >145mmol/l or <135 mmol/L
- •Preexisting serum chloremia >107mmol/l or < 98 mmol/L
- •Systemic steroid therapy (at any dose at time of inclusion)
- •Chronic liver disease (bilirubin >3 mg.dl)
- •Any signs of infection or sepsis defined as clear clinical evidence for active infection or current antibiotic therapy
研究组 & 干预措施
7.3% NaCl (intervention)
At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl NaCl by infusion pump over 60 minutes.
干预措施: Hypertonic saline (Drug)
0.9% NaCl (comparator)
At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.
干预措施: 0.9% saline (Drug)
结局指标
主要结局
total cumulative amount of fluids infused
时间窗: daily until ICU discharge, max until postoperative day 90
次要结局
- mortality(until postoperative day 90)
- total cumulative dose of inopressors per kg bodyweight /hour(until ICU discharge, max until postoperative day 90)
- time on inopressors(from ICU admission until stop of inopressors, max until postoperative day 90)
- postoperative weight gain(until postoperative day 6)
- total postoperative cumulative urinary output(daily until ICU discharge, max until postoperative day 90)
- variation in renal function markers(until postoperative day 6)
- variation in acid-base homeostasis(until postoperative day 6)
- variation in immune function(until postoperative day 6)
- time on the ventilator(from ICU admission until time of extubation, maximum 90 days)
- occurence of infection(occurence of infection during the index hospitalisation or subsequent admissions due to infection upto 90 postoperative days)
- length of stay(time to ICU/hospital-discharge however long this may take, maximum 90 days)
- readmissions to the ICU(readmissions to the ICU within postoperative 90 days)