跳至主要内容
临床试验/NCT01313975
NCT01313975已完成不适用

Disturbances of the Sodium and Fluid Balance in Patients With Severe Traumatic Brain Injury and Non-traumatic Subarachnoid Hemorrhage. A Systematic Observational Study

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Incidence of sodium-fluid disturbances

研究概览

简要总结

During the course of their acute illness patients with subarachnoid hemorrhage and severe traumatic brain injury often develop disturbances in their fluid balance and electrolyte homeostasis. These shifts are associated with worse outcome and increased morbidity.

The aim of this observational study is to systematically analyze the incidence, characteristics, potential diagnostic markers and predisposing factors of such disturbances. The investigators hypothesize that many disturbances cannot be classified with a standard diagnostic approach and that variable fluid management contributes to their pathophysiology.

Patients will be closely monitored clinically and the exact fluid and electrolyte balances will be recorded. Treatment decisions are within the bedside physicians responsibility. Baseline fluid management is standardised. No interventions are planned. The observation period equal the duration of ICU stay.

详细描述

Background

Electrolyte disturbances and fluid shifts are common in patients with subarachnoid hemorrhage (SAH) or traumatic brain injury (TBI). They usually have a rapid onset with impact on morbidity (possibly mortality) and length of stay. So far the understanding of underlying pathophysiologies and the contribution of iatrogenic influences is not fully understood.

Only limited evidence and data on classification, management and outcome of patients exists.

Objective

To describe the incidence, characteristics and duration of sodium and fluid disturbances in patients with SAH or TBI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • non-traumatic subarachnoid hemorrhage
  • severe traumatic brain injury (GCS<9)
  • Exclusion Criteria
  • younger than 18 years
  • time to admission after injury or bleed more than 7days
  • death expected in less than 12hours

排除标准

  • 未提供

结局指标

主要结局

Incidence of sodium-fluid disturbances

时间窗: 14 days

次要结局

  • Type of sodium abnormality(14 days)
  • Associated changes in natriuretic peptide levels(14 days)
  • Haemodynamic changes, 8hourly urine output, 8hourly fluid and sodium balance, changes in fluid management by treating doctors associated with sodium disturbances(14 days)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验