Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

Phase 4

Completed

• Conditions: Healthy Adult Volunteers
• Interventions: Drug: NaCl 0.9% in Glucose 5% with 40mEq Potassium; Drug: Glucion 5%

• Registration Number: NCT02822898
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-06
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-07
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isotonic Maintenance Fluid	NaCl 0.9% in Glucose 5% with 40mEq Potassium	Isotonic Maintenance Fluid
Hypotonic Maintenance Fluid	Glucion 5%	Hypotonic Maintenance Fluid

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital, Antwerp; 🇧🇪 Edegem, Belgium