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

Not Applicable

Completed

• Conditions: Nephropathy
• Interventions: Other: glucose 5%; Other: hypertonic saline 2,9 mg/ml; Other: isotonic saline 0,9 mg/ml

• Registration Number: NCT01414088
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
glucose	glucose 5%	glucose 5 %
hypertonic saline	hypertonic saline 2,9 mg/ml	hypertonic saline 2.9 mg/ml
isotonic saline	isotonic saline 0,9 mg/ml	isotonic saline 0.9 mg/ml

Primary Outcome Measures

Name	Time	Method
Renal biomarkers	day one	Urinary epithelial sodium channels (ENaC), Sodium-Chloride transporters (NCC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion

Secondary Outcome Measures

Name	Time	Method
blood hormones regulating salt, water and blood pressure	day one	plasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)

Trial Locations

Locations (1)

Medicinsk Forskning, Regionshospitalet i Holstebro; 🇩🇰 Holstebro, Denmark