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

Nephropathy Clinical Trial

— NARA  

Official title:

The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers for the Measurement of Sodium and Water Channel Activity in the Nephron in Healthy Young Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414088
• Other study ID #: EBP-JMJ-2011-1
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: May 17, 2013
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Nephropathy

Intervention

Other:
• isotonic saline 0,9 mg/ml
infusion, 23 ml/kg, during 50 minutes
• hypertonic saline 2,9 mg/ml
infusion, 7 ml/kg, during 50 minutes
• glucose 5%
infusion, 23 ml/kg, during 50 minutes

Locations

Country	Name	City	State
Denmark	Medicinsk Forskning, Regionshospitalet i Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal biomarkers	Urinary epithelial sodium channels (ENaC), Sodium-Chloride transporters (NCC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion	day one	No
Secondary	blood hormones regulating salt, water and blood pressure	plasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)	day one	No