Validation of Diagnostic Indices to Simplify Hyponatremia Therapy Assessment - A Randomized, Controlled, Parallel-group Clinical Trial in Hospitalized Patients on Thiazide Diuretics (THAT Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Serum Sodium Level
研究概览
简要总结
This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments.
详细描述
Thiazide or thiazide-like diuretics associated hyponatremia (thiazide associated hyponatremia, TAH) has a high prevalence in hospitalized patients. Patients might present either with a hypovolemic hyponatremia due to volume loss as a diuretic effect of thiazide, or with a syndrome of inadequate antidiuresis (SIAD) like hyponatremia in need of fluid restriction. Canonical urine indices are not useful in differential diagnosis, being directly influenced by thiazide itself. Current guidelines suggest the use of a clinical volume status assessment, but this approach has a poor diagnostic performance, with less than 50% of patients being rightly diagnosed thru that. The investigators showed in a retrospective analysis the possible role of strong apparent ion difference (aSID) and of chloride and potassium levels in urine (ChU) in differential diagnosis of TAH. The goal of this study is to investigate prospectively whether implementation of aSID and, in case of inconclusive aSID, ChU, allows a correct differential diagnosis and treatment of TAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients presenting at University Hospital Basel
- •aged 18 years or older
- •able to give informed consent as documented by signature
- •with serum sodium level < 133 mmol/l and serum osmolality < 300 mOsm/kg
- •with treatment with thiazide or thiazide-like diuretic
排除标准
- •symptomatic hyponatremia in need of 3% hypertonic solution or intensive care treatment
- •inability or contraindications to undergo the trial (i.e., any acute severe cardiovascular event requiring an immediate intervention)
- •decompensated liver cirrhosis CHILD C
- •decompensated heart failure NYHA III or higher
- •severe valve impairment
- •untreated adrenal insufficiency
- •severe kidney disease in need of dialysis
- •pregnancy or breastfeeding
- •end of life care
- •inability to follow the study procedures (i.e., language problem, dementia or critical illness).
研究组 & 干预措施
Standard Care Group
TAH patients randomised to the Standard Care Group will be followed by a physician not involved in the study.
干预措施: Standard Care (Other)
aSID/ChU Guided Therapy Group
TAH patients randomised to the aSID/ChU Guided Therapy Group will have aSID and ChU determined and, depending on the results, will be assigned to fluid administration with saline or drinking restriction.
干预措施: aSID/ChU Guided Therapy (Other)
结局指标
主要结局
Serum Sodium Level
时间窗: at baseline, 24 hours and up to 72 hours
Percentage of patients with an increase in serum sodium level \> 4 mmol/l at day 1 or \> 134 mmol/l in maximum 3 days in the aSID/ChU guided therapy group as compared to the standard care (control) group.
次要结局
- Diagnostic performance analyses of: aSID measured in blood gas analysis(at baseline, 24 hours and up to 72 hours)
- Diagnostic performance analyses of: not-invasive instrumental volume status assessment(at baseline, 24 hours and up to 72 hours)
- Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels(at baseline, 24 hours and up to 72 hours)
- Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels(at baseline, 24 hours and up to 72 hours)
- Diagnostic performance analyses of: aSID and ChU(at baseline, 24 hours and up to 72 hours)
- Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin(at baseline, 24 hours and up to 72 hours)
- Diagnostic performance analyses of: clinical volume status assessment(at baseline, 24 hours and up to 72 hours)