The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects

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

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-04-30

Brief Summary

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The kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. We do not know how these channels work in certain water and sodium accumulating medical conditions.

The purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.

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Detailed Description

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25 healthy subjects from age 18-45 are recruited.

Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories.

On the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes.

Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and creatinine.

Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in the nephron.

Conditions

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Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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glucose

glucose 5 %

Group Type PLACEBO_COMPARATOR

glucose 5%

Intervention Type OTHER

infusion, 23 ml/kg, during 50 minutes

isotonic saline

isotonic saline 0.9 mg/ml

Group Type ACTIVE_COMPARATOR

isotonic saline 0,9 mg/ml

Intervention Type OTHER

infusion, 23 ml/kg, during 50 minutes

hypertonic saline

hypertonic saline 2.9 mg/ml

Group Type ACTIVE_COMPARATOR

hypertonic saline 2,9 mg/ml

Intervention Type OTHER

infusion, 7 ml/kg, during 50 minutes

Interventions

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isotonic saline 0,9 mg/ml

infusion, 23 ml/kg, during 50 minutes

Intervention Type OTHER

hypertonic saline 2,9 mg/ml

infusion, 7 ml/kg, during 50 minutes

Intervention Type OTHER

glucose 5%

infusion, 23 ml/kg, during 50 minutes

Intervention Type OTHER

Other Intervention Names

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isotonic saline hypertonic saline glucose 5 %

Eligibility Criteria

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Inclusion Criteria

* healthy males and females
* age 18-45
* BMI range 18,5-30,0 kg/m2

Exclusion Criteria

* hypertension (ie ambulatory BP \>130 mmHg systolic or/and \>80 mmHg diastolic)
* history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease.
* alcohol abuse
* drug abuse
* smoking
* pregnancy or nursing
* blood donation within a month prior to examination
* Medical treatment apart from oral contraception

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes