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临床试验/CTRI/2025/03/082199
CTRI/2025/03/082199尚未招募不适用

Incidence and clinical implication of new onset dysnatremia in critically ill patients to ICU in a tertiary care hospital in eastern area.

Anushapreethi S1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年3月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
450
试验地点
1
主要终点
To investigate the impact of incidental sodium disorders on 28-day mortality of critically ill patients.

研究概览

简要总结

Phase 1: Observational

Collect baseline data on serum sodium at ICU admission and monitor daily sodium levels.

Classify sodium disorders as mild, moderate, or severe.

Phase 2: Interventional

Apply sodium management protocols tailored to each severity category.

Definitions of Sodium Disorders

Mild: Serum sodium levels between 125 to 150 mEq/L or a deviation of less than 10 mEq/L from the normal range.

Moderate: Serum sodium levels between 115 to 125 mEq/L or 150 to 160 mEq/L, or a deviation of 10 to 20 mEq/L from the normal range.

Severe: Serum sodium levels below 115 mEq/L or above 160 mEq/L, or a deviation of more than 20 mEq/L from the normal range.

Monitor outcomes such as mortality, ICU stay length

Primary Outcomes: Mortality rate and major complication rates.

Secondary Outcomes: Length of ICU stay, sodium level fluctuations

Until ICU discharge or death

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All adult patients admitted to the ICU for conditions other than primary sodium disorders.

排除标准

  • Patients admitted to the ICU primarily due to a sodium disorder.
  • Patients receiving 3%sodium chloride for cerebro-protective strategy Patients under 18 years of age, pregnant women, and those with end-stage renal disease on chronic dialysis.

结局指标

主要结局

To investigate the impact of incidental sodium disorders on 28-day mortality of critically ill patients.

时间窗: till 28 days ICU stay or death or discharge

次要结局

  • Determine the prevalence and progression of sodium disorders.(1. Length of ICU stay, fluctuations in sodium level)

研究者

发起方
Anushapreethi S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Sagarika Panda

IMS AND SUM HOSPITAL, Bhubaneswar

研究点 (1)

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