CompletedNCT02822898MIHMoSAUpdated Aug 9, 2016

Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

A Phase 4 interventional study of NaCl 0.9% in Glucose 5% with 40mEq Potassium and Glucion 5% in Healthy Adult Volunteers, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-09.

Sponsored by University Hospital, Antwerp · Phase 4, Interventional, and Supportive care

Phase: Phase 4
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Healthy Adult Volunteers

Keywords

Maintenance
Intravenous solutions
Intravenous fluids
Tonicity
Potassium
Sodium
Fluid retention

In context

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 12 participants (actual)

Study arms

Active comparator
Isotonic Maintenance Fluid
Isotonic Maintenance Fluid
Drug: NaCl 0.9% in Glucose 5% with 40mEq Potassium
Active comparator
Hypotonic Maintenance Fluid
Hypotonic Maintenance Fluid
Drug: Glucion 5%

Interventions

DrugNaCl 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
DrugGlucion 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

What researchers measure

Primary outcomes

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

Secondary outcomes

Amount of sodium retention / excretion (excreted sodium / administered sodium)
Sodium retention / excretion over study period (mean at 24 and 48h)
Time frame: 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.
Area under the electrolyte concentration curve (baseline level is reference line)
Time frame: 48h
Change of sodium and potassium level from its baseline value.
Area under the electrolyte concentration curve (baseline level is reference line)
Time frame: 48h

Other outcomes

Osmoregulatory Profile 1: urinary volume (mL)
Sequential changes in mean urinary volume (per fluid type) at T0-T12-T24-T36-T48.
Time frame: 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.
Time frame: 48h
Osmoregulatory Profile 3: serum antidiuretic hormone (ADH) (pg/mL)
Sequential changes in mean serum ADH (per fluid type) at T0-T24-T48.
Time frame: 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.
Time frame: 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.
Time frame: 48h
Volume Regulatory Profile 2: serum aldosterone (ng/dL)
Sequential changes in mean serum aldosterone (per fluid type) at T0-T24-T48.
Time frame: 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.
Time frame: 48h
Acid-Base Profile 1: serum chloride (mmol/L)
Sequential changes in mean serum chloride (per fluid type) at T0-T12-T24-T36-T48.
Time frame: 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.
Time frame: 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.
Time frame: 48h
Other Electrolytes Profile 1: Serum phosphate (mmol/L)
Sequential changes in mean serum phosphate (per fluid type) at T0-T24-T48.
Time frame: 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.
Time frame: 48h
Cortisol (µg/dL)
Serum cortisol as a measure of stress due to fasting.
Time frame: 48h
Bioelectrical impedance analysis 1: Total body water
Sequential changes in mean total body water (per fluid type) at T0-T24-T48.
Time frame: 48h
Bioelectrical impedance analysis : Extracellular volume
Sequential changes in mean extracellular volume (per fluid type) at T0-T24-T48.
Time frame: 48h

Study locations

1 site

University Hospital, Antwerp
Edegem, 2650, Belgium

References and documents

Publications

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. PubMed 12044376 ↗
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. PubMed 26422725 ↗
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. PubMed 28520883 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02822898
Lead sponsor: University Hospital, Antwerp
Collaborators: Baxter Healthcare Corporation
Responsible party: Niels Van Regenmortel (Senior Consultant, University Hospital, Antwerp) — Principal investigator
First posted: Jul 6, 2016
Start date: Jun 2016
Primary completion: Aug 2016
Completion: Aug 2016
Last update: Aug 9, 2016

Study contacts

Niels Van Regenmortel, M.D.

principal investigator · University Hospital, Antwerp

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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