Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 974
- 试验地点
- 1
- 主要终点
- Proportion of Isotonic Crystalloid Which is 0.9% Saline
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center
排除标准
- •Age<18 years old
研究组 & 干预措施
Physiologically balanced fluid
Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.
干预措施: Physiologically balanced fluid (Other)
0.9% sodium chloride
Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.
干预措施: 0.9% sodium chloride (Other)
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
- Increase in Serum Creatinine(30 days)
- Incidence of Hyperchloremia(30 days)
- 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)
- Highest Serum Sodium Between Enrollment and Day 30(30 days)
- Number of Patients With MAKE30(30 days)
- Peak Creatinine in the First 30 Days(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)
- Dialysis-free Survival to Day 28(28 days)
研究者
Todd Rice
Assistant Professor of Medicine
Vanderbilt University