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临床试验/NCT02822898
NCT02822898已完成4 期

Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Isotonic Maintenance Fluid

干预措施: NaCl 0.9% in Glucose 5% with 40mEq Potassium (Drug)

Hypotonic Maintenance Fluid

Active Comparator

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

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

Niels Van Regenmortel

Senior Consultant

University Hospital, Antwerp

研究点 (1)

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