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临床试验/NCT02345486
NCT02345486
已完成
不适用

Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 974 人2015年2月

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.

注册库
clinicaltrials.gov
开始日期
2015年2月
结束日期
2015年6月
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

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)

研究点 (1)

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