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NCT Number: NCT02822898

Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

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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Key information

Conditions

Healthy Adult Volunteers

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Antwerp

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Urine Output

    Time frame: 48h

    Urinary output over study period (as AUC).

  2. Body weight

    Time frame: 48h

    Body weight over study period (as AUC), used as a back up parameter for urinary output.

Secondary outcomes

  1. Amount of sodium retention / excretion (excreted sodium / administered sodium)

    Time frame: 48h

    Sodium retention / excretion over study period (mean at 24 and 48h)

  2. Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)

    Time frame: 48h

  3. Change of sodium level from its baseline value.

    Time frame: 48h

    Area under the electrolyte concentration curve (baseline level is reference line)

  4. Change of sodium and potassium level from its baseline value.

    Time frame: 48h

    Area under the electrolyte concentration curve (baseline level is reference line)

Other outcomes

  1. Osmoregulatory Profile 1: urinary volume (mL)

    Time frame: 48h

    Sequential changes in mean urinary volume (per fluid type) at T0-T12-T24-T36-T48.

  2. Osmoregulatory Profile 2: urinary osmolality (mOsm/kg)

    Time frame: 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.

  3. Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL)

    Time frame: 48h

    Sequential changes in mean serum ADH (per fluid type) at T0-T24-T48.

  4. Osmoregulatory Profile 4: thirst score (scale 0-5)

    Time frame: 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.

  5. Volume Regulatory Profile 1: urinary sodium (mmol/L)

    Time frame: 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.

  6. Volume Regulatory Profile 2: serum aldosterone (ng/dL)

    Time frame: 48h

    Sequential changes in mean serum aldosterone (per fluid type) at T0-T24-T48.

  7. Volume Regulatory Profile 3: urinary potassium (mmol/L)

    Time frame: 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.

  8. Acid-Base Profile 1: serum chloride (mmol/L)

    Time frame: 48h

    Sequential changes in mean serum chloride (per fluid type) at T0-T12-T24-T36-T48.

  9. Acid-Base Profile 2: serum apparent strong ion difference (mEq/L)

    Time frame: 48h

    Sequential changes in mean serum apparent strong ion difference (per fluid type) at T0-T12-T24-T36-T48.

  10. Acid-Base Profile 3: urinary anion gap (mmol/L)

    Time frame: 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.

  11. Other Electrolytes Profile 1: Serum phosphate (mmol/L)

    Time frame: 48h

    Sequential changes in mean serum phosphate (per fluid type) at T0-T24-T48.

  12. Other Electrolytes Profile 2: Red blood cell magnesium (mmol/L)

    Time frame: 48h

    Sequential changes in mean red blood cell magnesium (per fluid type) at T0-T24-T48.

  13. Cortisol (µg/dL)

    Time frame: 48h

    Serum cortisol as a measure of stress due to fasting.

  14. Bioelectrical impedance analysis 1: Total body water

    Time frame: 48h

    Sequential changes in mean total body water (per fluid type) at T0-T24-T48.

  15. Bioelectrical impedance analysis : Extracellular volume

    Time frame: 48h

    Sequential changes in mean extracellular volume (per fluid type) at T0-T24-T48.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Acronym: MIHMoSA

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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