Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Urine Output
研究概览
简要总结
The prescription of intravenous maintenance solutions - although widespread - lacks important data on the optimal sodium and potassium content, which has given rise to an important debate in the scientific literature. Our study compares two different infusion fluids in 12 healthy adult volunteers without renal failure in a single-blind randomized crossover design over two 48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at 25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum, clinical parameters and bioelectrical impedance analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, 18-70 years of age
- •BMI 17-45 kg/m².
- •Creatinine clearance >60 ml/min (according to eGFR CKD-EPI formula).
排除标准
- •Acute medical illness within 3 weeks of first study period
- •Chronic medication: under diuretic therapy or other chronic medication that interfere with urine output or induce urine retention. All chronic medication should be declared before being enrolled in the study.
- •Medical history:
- •cardiac failure,
- •malnourishment,
- •diabetes mellitus,
- •urological disease preventing spontaneous or complete emptying of the bladder,
- •any medical or non-medical issue preventing complaint-free fasting for 48 hours (e.g. active peptic ulcer, psychosis, substance abuse...)
- •Pregnancy
研究组 & 干预措施
Isotonic Maintenance Fluid
Isotonic Maintenance Fluid
干预措施: NaCl 0.9% in Glucose 5% with 40mEq Potassium (Drug)
Hypotonic Maintenance Fluid
Hypotonic Maintenance Fluid
干预措施: Glucion 5% (Drug)
结局指标
主要结局
Urine Output
时间窗: 48h
Urinary output over study period (as AUC).
Body weight
时间窗: 48h
Body weight over study period (as AUC), used as a back up parameter for urinary output.
次要结局
- Change of sodium level from its baseline value.(48h)
- Amount of sodium retention / excretion (excreted sodium / administered sodium)(48h)
- Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)(48h)
- Change of sodium and potassium level from its baseline value.(48h)
研究者
Niels Van Regenmortel
Senior Consultant
University Hospital, Antwerp
