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临床试验/NCT02164370
NCT02164370已完成不适用

Evaluation of Metabolic Acid-base Abnormalities in Pre-eclamptic Women Applying the Stewart-Fencl Approach

University of Washington2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2013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
120
试验地点
2
主要终点
Strong Ion Difference

研究概览

简要总结

Acid/base imbalances are not well understood in pre-eclamptics, and better tools are needed to allow a thorough and meaningful evaluation. Disorders of electrolytes and albumin are common findings [13, 14], and the impact of such disorders on acid-base homeostasis has increasingly been acknowledged [4, 15]. The purpose of this prospective case-control study is to evaluate acid-base status in 100 women with mild or severe pre-eclampsia and 25 healthy controls by applying the Stewart Fencl's physicochemical acid-base model. We hypothesize that several simultaneous, and possibly offsetting, metabolic acid-base disorders will be identified and quantified, and that these may be useful to guide clinicians in their medical management and indication for delivery. Intermediate and long-term goals are to evaluate the ability of the Stewart Fencl's physicochemical acid-base model to guide fluid management and predict maternal and neonatal outcomes.

详细描述

Studies evaluating acid/base imbalances are scarce in pre-eclamptics, and tools to thoroughly evaluate them are lacking. The detection of metabolic acidosis has been proposed as a diagnostic criterion for a severe disease state8, 11, however other studies entirely reject the presence of any metabolic acid-base disorder in pre-eclampsia10. One reason for this controversy may lie in the fact that no study performed a full comprehensive acid base analysis. Whereas some measured plasma pH, HCO3 and BE8, 11 others focused on AG1 or AG and HCO32, 10 only. Merely one study corrected the AG for low albumin1, and no study focused on independent variables. While some of the cited reports were based on retrospective chart review without differentiating mild and severe disease state1, 2, the few prospective studies available were of low sample size including a total number of 311 or 98women with severe pre-eclampsia. As indicated above, it is totally legitimate to use the traditional approach to describe changes in hydrogen ion concentration and HCO3. The Henderson-Hasselbach equation does differentiate well between respiratory and metabolic acid-base changes. However, it is unable to quantify metabolic causes15. SBE quantifies net change in metabolic acid-base status in vivo, but does not tell us about mechanisms16. The AG is insufficient to detect unmeasured anions17, 18, but when corrected for low albumin it does not detect all unmeasured cations16.

Intravascular volume depletion and disorders of electrolytes and albumin are common findings in pre-eclampsia1, 2 and the impact of such disorders on acid-base homeostasis has been increasingly acknowledged in the last decade3, 19. Decreased serum albumin has an alkalizing effect on plasma, resulting in hypoalbuminemic alkalosis. Furthermore, derangements in volume, sodium and chloride homeostasis, as well as the accumulation of unmeasured anions, are common findings in pre-eclampsia7 and may result in multiple acid-base disorders. The presence of hyponatremia or hyperchloremia has an acidifying effect on blood pH, whereas hypernatremia or hypochloremia lead to alkalosis. The accumulation of unmeasured anions, such as lactate or uric acid, will lead to acidemia, if not otherwise compensated3, 20.

We hypothesize that with comprehensive analysis, clinically significant and complex metabolic derangements might be discovered in pre-eclamptics that will potentially impact their care plan. To our knowledge, this will be the first time that the Stewart-Fencl methodology will be used to determine causes of acid-base status in pre-eclamptics, which takes into account the multiple, potentially opposing, electrochemical disturbances observed in this patient population.

Specific Aims

Aim 1: Prevalence

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with mild or severe pre-eclampsia

排除标准

  • Women in labor or presenting with chronic pulmonary disease, collagen disorders, history of lithium intoxication or history of methanol, ethanol or salicylates ingestion, urinary tract infection, chorioamnionitis, intrauterine fetal death, a body mass index (BMI) > 50 kg/m2 or acute asthma will be excluded.

结局指标

主要结局

Strong Ion Difference

时间窗: 1 year

Primary outcome measure is evaluation of strong ion difference (SID) in mild and severe pre-eclamptic women

次要结局

  • Sequential physicochemical acid-base analysis(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clemens Ortner

Assistant Professor

University of Washington

研究点 (2)

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