Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,000
- 试验地点
- 2
- 主要终点
- Hospital-free days to day 28
研究概览
简要总结
This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department.
详细描述
The administration of intravenous fluids is ubiquitous in the care of the acutely ill. Commonly available isotonic crystalloid solutions contain a broad spectrum of electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SaLt-ED will be a large, cluster-randomized trial enrolling adults requiring intravenous isotonic crystalloid administration and hospital admission from the Vanderbilt University Emergency Department from January 1st 2016 until April 30 2017. The primary endpoint will be hospital-free days to day 28.
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
- Single (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
- 否
入选标准
- •Patient in the Vanderbilt Adult Emergency Department
- •Felt by treating clinician to require intravenous isotonic crystalloid
- •Felt by treating clinician to require inpatient hospital admission
排除标准
- •Age < 18 years
结局指标
主要结局
Hospital-free days to day 28
时间窗: 28 days after enrollment
The number of days alive and free of hospitalization in the first 28 days after study enrollment. Patients alive at the time of discharge will be presumed to be alive at 28 days. A patient who dies before hospital discharge will receive zero hospital-free days. A patient who remains in the hospital 28 days after enrollment will receive zero hospital-free days.
次要结局
- Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury(30 days after enrollment censored at hospital discharge)
- Duration of new renal replacement therapy(30 days after enrollment)
- Change from baseline to peak creatinine(28 days after enrollment or hospital discharge, whichever occurs first)
- In-Hospital Mortality(30 days or hospital discharge, whichever occurs first)
- Major adverse kidney event by hospital discharge or day 30 (MAKE30)(30 days after enrollment)
- Hospital length of stay(Hospital length of stay assessed 90 days after enrollment)
- ICU-free days to day 28(28 days)
- Ventilator-free days to day 28(28 days)
- Peak creatinine(28 days after enrollment or hospital discharge, whichever occurs first)
- Incidence of metabolic acidosis and alkalosis(30 days after enrollment or hospital discharge, whichever occurs first)
- Vasopressor-free days(28 days)
- Receipt of new renal replacement therapy(30 days after enrollment or hospital discharge, whichever occurs first)
- Incidence of hyperchloremia and hypochloremia(30 days after enrollment or hospital discharge, whichever occurs first)
研究者
Wesley Self
Associate Professor of Emergency Medicine
Vanderbilt University