A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

Abbott18 个研究点分布在 1 个国家目标入组 45 人开始时间: 2002年1月最近更新: 2006年8月2日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Abbott
入组人数: 45
试验地点: 18
主要终点: The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Double

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

•ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.

排除标准

•Serum creatinine greater than 2.5 mg/dL

结局指标

主要结局

The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.

次要结局

未报告次要终点

研究者

发起方

Abbott

申办方类型

Industry

研究点 (18)

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