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临床试验/NCT04744987
NCT04744987已完成不适用

Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia

Hospital San Carlos, Madrid1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2019年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia

研究概览

简要总结

Retrospective study that analyzes the changes in serum creatinine as a tool to correctly classify the volemic status volemic status (euvolemia vs hypovolemia) of the patients with hyponatremia.

详细描述

This study evaluates the usefulness of the changes in serum creatinine in differentiating between euvolemia and hypovolemia in hyponatremic patients. Changes in serum creatinine were retrospectively analyzed . The latter was calculated subtracting the serum creatinine value of eunatremia from that of hyponatremia, and was categorized as an increase when it was "positive", or "decrease/no change" when it was negative or equal to zero. The percentual change in serum creatinine was also calculated.

Two groups of patients were selected for the current study. First group was conformed by patients with hypovolemic hyponatremia, and second group by patients with euvolemic hyponatremia. Data from eunatremia as well as the hyponatremic episode were collected. Both groups were matched in Receiver operating characteristic curve analyzes where both arithmetical and percentual changes in serum creatinine were assessed and cut-off points were selected for an additional Odd Ratio analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hypovolemic hyponatremia secondary to any cause
  • Patients with euvolemic hyponatremia caused by Syndrome of inappropriate antidiuresis
  • Complete clinical volemia assessment during hyponatremia.
  • Presence of serum creatinine measured in eunatremia as well as in hyponatremic episodes.

排除标准

  • Pregnants.
  • Patients with a prior history of diabetes, advanced chronic kidney disease (glomerular filtrate rate below 30 ml/min), cirrhosis, or heart failure were excluded.
  • Patients with hypervolemic hyponatremia.

结局指标

主要结局

Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia

时间窗: 4 months

Area under the curve from the Receiver operating characteristic curve analysis were calculated for the changes in serum creatinine. Probabilities of each evaluated tool (arithmetic and percentual change in serum creatinine) to correctly classified the volemic status of the hyponatremic patients were calculated.

次要结局

  • Ratio of Correct volemic classification of hyponatremia when Changes in Serum creatinine were used.(4 months)
  • Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Gabriel Ruiz Sánchez

Principal investigator

Hospital San Carlos, Madrid

研究点 (1)

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