Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

Overview

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.

Full Title of Study: “Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2016

Interventions

  • Drug: NaCl 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
  • Drug: Glucion 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

Arms, Groups and Cohorts

  • Active Comparator: Isotonic Maintenance Fluid
    • Isotonic Maintenance Fluid
  • Active Comparator: Hypotonic Maintenance Fluid
    • Hypotonic Maintenance Fluid

Clinical Trial Outcome Measures

Primary Measures

  • Urine Output
    • Time Frame: 48h
    • Urinary output over study period (as AUC).
  • Body weight
    • Time Frame: 48h
    • Body weight over study period (as AUC), used as a back up parameter for urinary output.

Secondary Measures

  • Amount of sodium retention / excretion (excreted sodium / administered sodium)
    • Time Frame: 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)
    • Time Frame: 48h
  • Change of sodium level from its baseline value.
    • Time Frame: 48h
    • Area under the electrolyte concentration curve (baseline level is reference line)
  • Change of sodium and potassium level from its baseline value.
    • Time Frame: 48h
    • Area under the electrolyte concentration curve (baseline level is reference line)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Antwerp
  • Collaborator
    • Baxter Healthcare Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Niels Van Regenmortel, Senior Consultant – University Hospital, Antwerp
  • Overall Official(s)
    • Niels Van Regenmortel, M.D., Principal Investigator, University Hospital, Antwerp

References

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.

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.

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