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临床试验/NCT03840629
NCT03840629已完成不适用

Impact of Maintenance Fluid Tonicity on Natraemia in Post-surgical Adult Patients

National University Hospital, Singapore0 个研究点目标入组 659 人开始时间: 2014年11月13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
659
主要终点
Hyponatraemia

研究概览

简要总结

Retrospective audit of adult patients who underwent major surgery in our institution, and biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity administered peri-operatively.

详细描述

Hyponatraemia is a common electrolyte abnormality which is hospital-acquired in two-thirds of cases, and can lead to obtundation, seizures, encephalopathy and death. In children, the use of hypotonic maintenance fluids had been routine until recent evidence showing that they were associated with an increased incidence of hyponatraemia, with consequent increases in morbidity and mortality. Comparative data in adults is limited.

In our institution, the National University Hospital, Singapore, a hypotonic solution of 0.33% saline pre-mixed with 10mM KCl per 500ml has been in common use for years for surgical patients. This is largely based on calculations of daily requirements (1-1.5mM/kg of sodium and 1mM/kg of potassium) and reduction of risk associated with measuring out KCl and injecting it into drip bags. However, this solution is hypotonic (134mM) compared to plasma, and its administration could theoretically increase the risk of subsequent hyponatraemia.

In this single-centre retrospective observational study, we aim to compare the biochemical outcomes of hospitalised surgical adult patients who have been given hypotonic (0.33% saline) compared to isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution) between March and September 2013. We hypothesize that hypotonic solutions are more likely to cause a post-operative hyponatraemia and subsequent complications compared to their isotonic counterparts. The complications of hyponatraemia are defined in this study as new ICU admissions and increased mortality.

Inappropriate fluid prescription is a contributor to iatrogenic morbidity and mortality. Our study aims to evaluate the safety of a hypotonic solution in standard use. The results will help guide fluid choice, especially in the absence of current evidence-based national guidelines. As it is a retrospective study, there are no risks involved.

This is a single-centre retrospective observational study based on electronic medical records collected between the months of March 2012 and September 2013. Patients will be divided into two groups - one which received hypotonic 0.33% saline, and another which received isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution). Serum sodium, chloride, bicarbonate and creatinine measured pre-operatively will be compared to post-operative values obtained 24-48 hours later.

研究设计

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

入排标准

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

入选标准

  • exclusive administration of either fluid types.

排除标准

  • Patients who received saline boluses

结局指标

主要结局

Hyponatraemia

时间窗: 48 to 72 hrs post surgery

Hyponatraemia post surgery

次要结局

  • Hypokalemia(48 to 72 hrs post surgery)
  • Acute kidney injury(48 to 72 hrs post surgery)

研究者

申办方类型
Other
责任方
Sponsor

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