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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotonic Maintenance Fluid | Active Comparator | Isotonic Maintenance Fluid |
|
| Hypotonic Maintenance Fluid | Active Comparator | Hypotonic Maintenance Fluid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaCl 0.9% in Glucose 5% with 40mEq Potassium | Drug | NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Osmoregulatory Profile 1: urinary volume (mL) | Sequential changes in mean urinary volume (per fluid type) at T0-T12-T24-T36-T48. | 48h |
| Osmoregulatory Profile 2: urinary osmolality (mOsm/kg) | 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. |
Inclusion Criteria:
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:
any medical or non-medical issue preventing complaint-free fasting for 48 hours (e.g. active peptic ulcer, psychosis, substance abuse…)
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Niels Van Regenmortel, M.D. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Antwerp | Edegem | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12044376 | Background | Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet. 2002 May 25;359(9320):1812-8. doi: 10.1016/S0140-6736(02)08711-1. | |
| 26422725 | Background | Moritz ML, Ayus JC. Maintenance Intravenous Fluids in Acutely Ill Patients. N Engl J Med. 2015 Oct;373(14):1350-60. doi: 10.1056/NEJMra1412877. No abstract available. |
| Label | URL |
|---|---|
| NICE guideline on Intravenous Fluid Therapy in Adults in Hospital | View source |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Glucion 5% | Drug | 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 |
|
| 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 |
| 48h |
| Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL) | Sequential changes in mean serum ADH (per fluid type) at T0-T24-T48. | 48h |
| Osmoregulatory Profile 4: thirst score (scale 0-5) | 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. | 48h |
| Volume Regulatory Profile 1: urinary sodium (mmol/L) | 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. | 48h |
| Volume Regulatory Profile 2: serum aldosterone (ng/dL) | Sequential changes in mean serum aldosterone (per fluid type) at T0-T24-T48. | 48h |
| Volume Regulatory Profile 3: urinary potassium (mmol/L) | 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. | 48h |
| Acid-Base Profile 1: serum chloride (mmol/L) | Sequential changes in mean serum chloride (per fluid type) at T0-T12-T24-T36-T48. | 48h |
| Acid-Base Profile 2: serum apparent strong ion difference (mEq/L) | Sequential changes in mean serum apparent strong ion difference (per fluid type) at T0-T12-T24-T36-T48. | 48h |
| Acid-Base Profile 3: urinary anion gap (mmol/L) | 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. | 48h |
| Other Electrolytes Profile 1: Serum phosphate (mmol/L) | Sequential changes in mean serum phosphate (per fluid type) at T0-T24-T48. | 48h |
| Other Electrolytes Profile 2: Red blood cell magnesium (mmol/L) | Sequential changes in mean red blood cell magnesium (per fluid type) at T0-T24-T48. | 48h |
| Cortisol (µg/dL) | Serum cortisol as a measure of stress due to fasting. | 48h |
| Bioelectrical impedance analysis 1: Total body water | Sequential changes in mean total body water (per fluid type) at T0-T24-T48. | 48h |
| Bioelectrical impedance analysis : Extracellular volume | Sequential changes in mean extracellular volume (per fluid type) at T0-T24-T48. | 48h |
| 28520883 | Derived | Van Regenmortel N, De Weerdt T, Van Craenenbroeck AH, Roelant E, Verbrugghe W, Dams K, Malbrain MLNG, Van den Wyngaert T, Jorens PG. Effect of isotonic versus hypotonic maintenance fluid therapy on urine output, fluid balance, and electrolyte homeostasis: a crossover study in fasting adult volunteers. Br J Anaesth. 2017 Jun 1;118(6):892-900. doi: 10.1093/bja/aex118. |
| GIFTASUP guidelines | View source |