Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Acute Kidney Injury
- 发起方
- Vanderbilt University
- 入组人数
- 974
- 试验地点
- 1
- 主要终点
- Proportion of Isotonic Crystalloid Which is 0.9% Saline
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.
研究者
Todd Rice
Assistant Professor of Medicine
Vanderbilt University
入排标准
入选标准
- •Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center
排除标准
- •Age\<18 years old
结局指标
主要结局
Proportion of Isotonic Crystalloid Which is 0.9% Saline
时间窗: 30 days
Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.0 (only saline received).
次要结局
- Proportion of Isotonic Crystalloid Which is Physiologically Balanced(30 days)
- Total Intravenous Input(30 days)
- Total Isotonic Crystalloid Input(30 days)
- Total Intravenous Colloid Input(30 days)
- Persistent Renal Dysfunction(30 days)
- Incidence of Severe Hypochloremia(30 days)
- Total Intravenous Blood Product Administration(30 days)
- Lowest Bicarbonate Concentration Between Enrollment and Day 30(30 days)
- Intensive Care Unit Free Days to Day 28(28 days)
- Ventilator-free Days (VFD) to Day 28(28 days)
- Peak Creatinine in the First 30 Days(30 days)
- Highest Serum Sodium Between Enrollment and Day 30(30 days)
- Number of Patients With MAKE30(30 days)
- Incidence of Acute Kidney Injury(30 days)
- Highest Serum Chloride Between Enrollment and Day 30(30 days)
- In-hospital Mortality(30 days)
- New Use of Renal Replacement Therapy(30 days)
- Number of Contraindications(30 days)
- Increase in Serum Creatinine(30 days)
- Incidence of Hyperchloremia(30 days)
- Dialysis-free Survival to Day 28(28 days)