Clinical trial NCT02822898: Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults
Official title: Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Adult Volunteers
Keywords: Maintenance
Intravenous solutions
Intravenous fluids
Tonicity
Potassium
Sodium
Fluid retention
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2016-07-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Urine Output
timeFrame: 48h
measure: Body weight
timeFrame: 48h
Secondary outcomes:
measure: Amount of sodium retention / excretion (excreted sodium / administered sodium)
timeFrame: 48h
measure: Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)
timeFrame: 48h
measure: Change of sodium level from its baseline value.
timeFrame: 48h
measure: Change of sodium and potassium level from its baseline value.
timeFrame: 48h
Other outcomes:
measure: Osmoregulatory Profile 1: urinary volume (mL)
timeFrame: 48h
measure: Osmoregulatory Profile 2: urinary osmolality (mOsm/kg)
timeFrame: 48h
measure: Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL)
timeFrame: 48h
measure: Osmoregulatory Profile 4: thirst score (scale 0-5)
timeFrame: 48h
measure: Volume Regulatory Profile 1: urinary sodium (mmol/L)
timeFrame: 48h
measure: Volume Regulatory Profile 2: serum aldosterone (ng/dL)
timeFrame: 48h
measure: Volume Regulatory Profile 3: urinary potassium (mmol/L)
timeFrame: 48h
measure: Acid-Base Profile 1: serum chloride (mmol/L)
timeFrame: 48h
measure: Acid-Base Profile 2: serum apparent strong ion difference (mEq/L)
timeFrame: 48h
measure: Acid-Base Profile 3: urinary anion gap (mmol/L)
timeFrame: 48h
measure: Other Electrolytes Profile 1: Serum phosphate (mmol/L)
timeFrame: 48h
measure: Other Electrolytes Profile 2: Red blood cell magnesium (mmol/L)
timeFrame: 48h
measure: Cortisol (µg/dL)
timeFrame: 48h
measure: Bioelectrical impedance analysis 1: Total body water
timeFrame: 48h
measure: Bioelectrical impedance analysis : Extracellular volume
timeFrame: 48h
Locations:
city: Edegem
country: Belgium
facility: University Hospital, Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Niels Van Regenmortel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.