Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Adult Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Isotonic Maintenance Fluid

Group Type ACTIVE_COMPARATOR

NaCl 0.9% in Glucose 5% with 40mEq Potassium

Intervention Type DRUG

NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h

Hypotonic Maintenance Fluid

Group Type ACTIVE_COMPARATOR

Glucion 5%

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes