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临床试验/NCT02652364
NCT02652364已完成不适用

Strong Ion Gap as Prognostic Indicator for Adult Patients Admitted With Shock to the Intensive Care Units

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2015年10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
112
试验地点
1
主要终点
mortality

研究概览

简要总结

This study evaluates if strong ion gap on admission or 24 hours after admission to critical care unit can predict 28 day outcome in patients admitted with shock due to any cause

详细描述

Metabolic acidosis is frequently found in patients with shock. Traditional methods of evaluating acid-base status can underestimate and even miss complex acid-base disorders particularly in the setting of hypoalbuminemia, hypo/hypernatraemia and hypo/hyperchloraemia .An alternative approach to acid-base balance, based on chemical and physical principles, and was proposed by Peter Stewart more than 30 years ago. Later in 1992 Figge and Fencl modified the strong ion difference, which corresponds with the net charge balance of all strong ions present in a given solution (the ''Fencl-Stewart'' approach). The strong ion gap (SIG) which corresponds with the difference between the apparent strong ion difference and the effective strong ion difference was proposed by Kellum. Compared to the Fencl- Stewart approach SIG has more accuracy and bedside practicality.

As the SIG is calculated from all known charged components of blood, it is considered the gold standard for the quantification of unmeasured anions. In contrast, the traditional anion gap calculation only factors in sodium, potassium, chloride and bicarbonate. In healthy humans, the SIG equals zero. In critically ill patients, a high SIG, defined as >2mEq/L, indicates the accumulation of unmeasured anions in blood as a cause of acidosis. The unmeasured anions include lactate, ketoacids, uraemic acids and toxins like ethylene glycol and methanol. Studies found that a higher SIG on admission to intensive care unit is associated with poorer outcomes, and has a role in prediction of outcome in septic patients. However this finding is not consistent.

In addition it was found that there is a significant difference in the threshold for SIG value associated with higher mortality. The abnormal SIG value in American studies are described around 5 mEq/l . However studies from Europe and Australia reported higher values in the range of 8-13 mEq/l. It is speculated that this difference is due to exogenous sources of unmeasured ions from gelatin based intravenous fluids used for resuscitation. Interestingly studies using gelatine- based fluids also failed to show a correlation between SIG and mortality. SIG values have not been published in critically ill Asian adult patients admitted to the Intensive Care Units (ICU) as yet. We aim to find the SIG for these patients in the hope that it will be useful for predicting outcome. Our hypothesis is that SIG is an independent predictor of outcomes in adult patient with shock.

We propose to conduct this prospective observational study in the surgical and medical ICUs of 2 hospitals in Singapore. (Singapore General Hospital and Changi General Hospital) We aim to enrol 112 of you admitted to the ICU with shock of any etiology. Shock is defined as persistence of arterial hypotension despite adequate volume resuscitation. Hypotension is defined as systolic pressure <90mmHg, Mean arterial pressure (MAP)<70 mmHg or drop in SBP >40 mmHg from baseline. 30ml/kg of fluid is considered as the threshold for adequate volume resuscitation.

The methodology of this observational study was approved by Sing health Institutional review Board, Singapore. We will include you if you have persistent hypotension despite adequate fluid resuscitation as defined above or if you require vasopressors or inotropes to maintain MAP above 65mmHg on admission.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with any form of shock on admission to ICU

排除标准

  • CKD stage 3 and above (GFR> 60)
  • Chronic liver failure( Child's B grade and above)
  • Patients who were already recruited for this study
  • Patients expected to die within next 48 hrs upon admission

结局指标

主要结局

mortality

时间窗: 28 days

次要结局

  • Duration of ICU stay(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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