NCT03658850Unknown2 期
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- hypernatremia correction
研究概览
简要总结
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
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
- Triple (Participant, Care Provider, Investigator)
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 for intensive care,
- •Over 18 years of age,
- •Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
- •Mean arterial pressure greater than 65mmHg
排除标准
- •Absence of consent to participate in the study
- •Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate> 4mMol / L.
- •Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
- •Unavailable enteral route.
- •Use of hydrochlorothiazide in the last 7 days of ICU admission.
- •History of allergy or intolerance to hydrochlorothiazide or other thiazides.
- •Nephrogenic Diabetes Insipidus.
- •Renal impairment KDIGO 3
- •Indication of renal replacement therapy.
- •Acute neurological insult.
- •Heart failure American Heart Association classification (AHA), class D.
- •Liver cirrhosis Child-Pugh C.
- •Pregnant women
- •Exclusive palliative care
- •Dying, with expected survival less than 48 hours
研究组 & 干预措施
Intervention
Active Comparator
the experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days.
干预措施: Hydrochlorothiazide 50Mg (Drug)
Control
Placebo Comparator
placebo group will receive one tablet or equivalent volume of enteral solution of inert substance
干预措施: Placebos (Drug)
结局指标
主要结局
hypernatremia correction
时间窗: DAY 3
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
次要结局
- renal replacement therapy(6 months)
- mechanical ventilation(6 months)
- mortality(6 months)
- vasoactive drugs(6 months)
- serious adverse events(6 months)
研究者
André Luiz Nunes Gobatto
Principal Investigator
University of Sao Paulo
研究点 (1)
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