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Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit (HYPNIC)

2019年4月10日 更新者:Eveline Mestrom、Catharina Ziekenhuis Eindhoven

Insight in the Development and Recovery of Hypernatremia in Critically Ill Patients.

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

研究概览

地位

完全的

条件

详细说明

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. The main mechanism is an imbalance between sodium and total body water. Consequently, this poses multiple factors to play a role in the development of hypernatremia. multifactorial. Previous studies focused on predictors in the development of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that correction of hypernatremia can reduce the associated mortality risk.

This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

研究类型

观察性的

注册 (实际的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Noord-Brabant
      • Eindhoven、Noord-Brabant、荷兰、5623 EJ
        • Catharina Hospital Eindhoven

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

As a cardiothoracic and oncologic center, the ICU in the Catharina Hospital mostly admits postoperative patients. Other categories of admission are sepsis, respiratory insufficiency, intoxication. However, all patients with an indication for hemodynamic, respiratory of metabolic monitoring will be admitted. The Catharina Hospital is a tertiairy referral hospital. The ICU has 32 beds.

描述

Inclusion Criteria:

  • Adults >17 years old
  • Admitted >48 hours in ICU

Exclusion Criteria:

- Expected discharge same day as day of inclusion

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
ICU patients
All patients admitted to ICU >48 hours will be included. Eventually, a number of these patients will develop hypernatremia and form the cases. The patients who will not develop hypernatremia will be assigned as the controls.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Development of hypernatremia
大体时间:During ICU admission
Serum sodium levels >145mmol/L
During ICU admission
Recovery of hypernatremia
大体时间:During ICU admission
Serum sodium levels returning back to levels below 146mmol/L
During ICU admission

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间:During ICU admission as well as during hospital admission
Patient did or did not pass away.
During ICU admission as well as during hospital admission
Length of stay
大体时间:Admission in ICU as well as in hospital
Number of days of admission
Admission in ICU as well as in hospital

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Eveline Mestrom, MD、Catharina Ziekenhuis Eindhoven

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年5月25日

初级完成 (实际的)

2018年12月20日

研究完成 (实际的)

2019年4月10日

研究注册日期

首次提交

2018年11月21日

首先提交符合 QC 标准的

2018年11月21日

首次发布 (实际的)

2018年11月26日

研究记录更新

最后更新发布 (实际的)

2019年4月12日

上次提交的符合 QC 标准的更新

2019年4月10日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HYPNIC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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