Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Antwerp
• Collaborator: Baxter Healthcare Corporation
• Treatments: Pharmaceutical Solutions

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