Healthy adult volunteers
Conditions
Interventions
Trade Name: Sodium chloride 0.9% in Glucose 5%
Pharmaceutical Form: Solution for infusion
Trade Name: Glucion 5%
Pharmaceutical Form: Solution for infusion
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Normal adults, 18-70 years of age - BMI 17-45 kg/m². - Creatinine clearance >60 ml/min (according to eGFR CKD-EPI formula). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion 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: o cardiac failure, o malnourishment, o diabetes mellitus, o 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,…) - obesity with a BMI >45 - Pregnanc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there an association between the tonicity of a maintenance solution and fluid retention in subjects fasting for 48 hours? Although one of the most broadly used interventions in hospital medicine, there is an important lack of clinical research on maintenance fluids. The NICE guidelines (Clinical Guideline 174) recommend the use of hypotonic maintenance in adult patients, based on old dietary reference values and on the finding that fluid and sodium overload can lead to increased perioperative morbidity (Lobo et al, Lancet 2002). On the other hand, a debate was started recently on the need to extrapolate pediatric recommendations to adult care, promoting isotonic maintenance solutions to avoid hyponatremia-associated morbidity (Moritz et al, N Engl J Med 2015;373:1350-60 + subsequent letters to the editor).;Secondary Objective: Is there an association between the tonicity of a maintenance solution and electrolyte disturbances in subjects fasting for 48 hours? How does the human body handles maintenance fluids with two different tonicities. Effect of both solutions on bioelectrical impedance analysis (total body water, intra- en extracellular water volume);Primary end point(s): Total urine volume after 48h (after last micturition) (isotonic vs. hypotonic maintenance), measured as area under the urinary output curve ;Timepoint(s) of evaluation of this end point: Urine samples: Subjects void their bladder as the urge rises. Exact timing and volume of diuresis is noted. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Fluid balance (after correction for insensible losses) and body weight at 48 hours (isotonic vs. hypotonic maintenance). • Mean sodium and potassium concentration at T48. Extra: description and visualization of urine volume, osmolality and sodium concentration, ADH, aldosterone over the course of 48 hours (isotonic vs. hypotonic maintenance). • Incidence of hyponatremia ( 145 mmol/L) during the study period (isotonic vs. hypotonic maintenance with known potassium content). • Strong ion difference (apparent and effective) and strong ion gap (unbalanced isotonic vs. balanced hypotonic maintenance solutions). • TBW and extracellular volume assessed by bio-impedance analysis at 36/48h (isotonic vs. hypotonic maintenance);Timepoint(s) of evaluation of this end point: Subjects void their bladder as the urge rises. Exact timing and volume of diuresis is noted. Serum samples at T0-12-24-36-48 Bioelectrical impedance analysis at T0-24-48 Clinical parameters (blood pressure, heart rate, thirst score) at T0-24-48 Body weight at T0-12-24-36-48 | — |
Countries
Belgium
Contacts
Public ContactNiels Van Regenmortel
Department of Intensive Care Medicine - Antwerp University Hospital
Outcome results
None listed