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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01414088
Acronym
NARA
Enrollment
23
Registered
2011-08-11
Start date
2011-04-30
Completion date
2012-04-30
Last updated
2013-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephropathy

Keywords

Nephrology, ENaC, NCC, NKCC, Sodium channels, renal biomarkers

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.

Interventions

OTHERisotonic saline 0,9 mg/ml

infusion, 23 ml/kg, during 50 minutes

OTHERhypertonic saline 2,9 mg/ml

infusion, 7 ml/kg, during 50 minutes

infusion, 23 ml/kg, during 50 minutes

Sponsors

Regional Hospital Holstebro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Renal biomarkersday oneUrinary epithelial sodium channels (ENaC), Sodium-Chloride transporters (NCC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion

Secondary

MeasureTime frameDescription
blood hormones regulating salt, water and blood pressureday oneplasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026