Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Adult Volunteers

Intervention / Treatment
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* Drug: NaCl 0.9% in Glucose 5% with 40mEq Potassium
* Drug: Glucion 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults, 18-70 years of age BMI 17-45 kg/m². Creatinine clearance >60 ml/min (according to eGFR CKD-EPI formula). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isotonic Maintenance Fluid<br>Isotonic Maintenance Fluid | Drug: NaCl 0.9% in Glucose 5% with 40mEq Potassium<br>* NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h<br>|
| Active Comparator: Hypotonic Maintenance Fluid<br>Hypotonic Maintenance Fluid | Drug: Glucion 5%<br>* Glucion 5% (premixed solution containing 54 mmol/L sodium and 26 mmol/L potassium amongst others), administered at 25 mL/kg IBW/h for 48h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Output | Urinary output over study period (as AUC). | 48h | 
| Body weight | Body weight over study period (as AUC), used as a back up parameter for urinary output. | 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of sodium retention / excretion (excreted sodium / administered sodium) | Sodium retention / excretion over study period (mean at 24 and 48h) | 48h | 
| Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L) |  | 48h | 
| Change of sodium level from its baseline value. | Area under the electrolyte concentration curve (baseline level is reference line) | 48h | 
| Change of sodium and potassium level from its baseline value. | Area under the electrolyte concentration curve (baseline level is reference line) | 48h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maintenance, Intravenous solutions, Intravenous fluids, Tonicity, Potassium, Sodium, Fluid retention