Healthy Adult Volunteers
Conditions
Keywords
Maintenance, Intravenous solutions, Intravenous fluids, Tonicity, Potassium, Sodium, Fluid retention
Brief summary
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.
Interventions
DRUGNaCl 0.9% in Glucose 5% with 40mEq Potassium
NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h
DRUGGlucion 5%
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
Sponsors
Baxter Healthcare Corporation
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Output | 48h | Urinary output over study period (as AUC). |
| Body weight | 48h | Body weight over study period (as AUC), used as a back up parameter for urinary output. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of sodium retention / excretion (excreted sodium / administered sodium) | 48h | Sodium retention / excretion over study period (mean at 24 and 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. | 48h | Area under the electrolyte concentration curve (baseline level is reference line) |
| Change of sodium and potassium level from its baseline value. | 48h | Area under the electrolyte concentration curve (baseline level is reference line) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Volume Regulatory Profile 3: urinary potassium (mmol/L) | 48h | Sequential changes in mean urinary potassium (per fluid type). Urinary potassium is determined on a sample of every individual diuresis. Subjects urinate as the urge rises. |
| Acid-Base Profile 1: serum chloride (mmol/L) | 48h | Sequential changes in mean serum chloride (per fluid type) at T0-T12-T24-T36-T48. |
| Acid-Base Profile 2: serum apparent strong ion difference (mEq/L) | 48h | Sequential changes in mean serum apparent strong ion difference (per fluid type) at T0-T12-T24-T36-T48. |
| Acid-Base Profile 3: urinary anion gap (mmol/L) | 48h | Sequential changes in mean urinary anion gap (per fluid type). Urinary potassium is determined on a sample of every individual diuresis. Subjects urinate as the urge rises. |
| Osmoregulatory Profile 1: urinary volume (mL) | 48h | Sequential changes in mean urinary volume (per fluid type) at T0-T12-T24-T36-T48. |
| Other Electrolytes Profile 2: Red blood cell magnesium (mmol/L) | 48h | Sequential changes in mean red blood cell magnesium (per fluid type) at T0-T24-T48. |
| Cortisol (µg/dL) | 48h | Serum cortisol as a measure of stress due to fasting. |
| Bioelectrical impedance analysis 1: Total body water | 48h | Sequential changes in mean total body water (per fluid type) at T0-T24-T48. |
| Bioelectrical impedance analysis : Extracellular volume | 48h | Sequential changes in mean extracellular volume (per fluid type) at T0-T24-T48. |
| Other Electrolytes Profile 1: Serum phosphate (mmol/L) | 48h | Sequential changes in mean serum phosphate (per fluid type) at T0-T24-T48. |
| Osmoregulatory Profile 2: urinary osmolality (mOsm/kg) | 48h | Sequential changes in mean urinary osmolality (per fluid type). Urinary osmolality is determined on a sample of every individual diuresis. Subjects urinate as the urge rises. |
| Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL) | 48h | Sequential changes in mean serum ADH (per fluid type) at T0-T24-T48. |
| Osmoregulatory Profile 4: thirst score (scale 0-5) | 48h | Sequential changes in mean thirst score (per fluid type) at T0-T12-T24-T36-T48. The thirst score is a subjective score on a scale of 0-5. |
| Volume Regulatory Profile 1: urinary sodium (mmol/L) | 48h | Sequential changes in mean urinary sodium (per fluid type). Urinary sodium is determined on a sample of every individual diuresis. Subjects urinate as the urge rises. Urinary sodium is used to calculate the fractional excretion of sodium. |
| Volume Regulatory Profile 2: serum aldosterone (ng/dL) | 48h | Sequential changes in mean serum aldosterone (per fluid type) at T0-T24-T48. |
Countries
Belgium
Outcome results
None listed