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Effect of Hypertonic Sodium Chloride on Urinary Biomarkers in Healthy Subjects and Patients With Chronic Kidney Disease

Effect of Intravenous Sodium Chloride on Urinary Biomarkers for Measurement of Sodium- and Water Channel Activity in the Nephron in Healthy Subject an Patients With Chronic Kidney Disease. A Case Control Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01623661
Acronym
CASE
Enrollment
47
Registered
2012-06-20
Start date
2011-12-31
Completion date
2013-06-30
Last updated
2014-03-04

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

Conditions

Nephropathy

Keywords

Nephrology, chronic kidney disease, sodium-channels, water-channels, BCM

Brief summary

Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy subjects. Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be measured after an infusion with hypertonic saline in CKD patients and healthy subjects.

Detailed description

The fractional sodium excretion is elevated as high as 10-20% In patients with chronic kidney disease (CKD) Changes in the sodium intake results in a slower expansion and/or reduction in extracellular fluid in CKD patients. Urinary biomarkers reflects the kidneys transport of sodium and water in the nephron. Changes in the sodium-and water channel activity is induced by intervention with hypertonic Saline (3.0%) The change in sodium-and water channel activity is followed by change in extracellular and intracellular fluid compartments and the plasma concentration of vasoactive hormones. The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), the activity of the sodium-and water channels, the extra- and intracellular fluid compartments and the plasma concentration of Vasoactive hormones in patients with CKD and in healthy subjects. Subjects and patients are examined during one examination day. Four days prior to the examination day the subjects consume a standardized diet based on the amount of sodium and calories. On the examination day the subjects receive an infusion with hypertonic saline. Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) are measured to evaluate the activity of sodium channels in the nephron and changes in fluid compartments are measured by body composition monitor.

Interventions

OTHERhypertonic saline

hypertonic saline 3.0 % (7 ml/kg)

Sponsors

Regional Hospital Holstebro
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. healthy subjects * healthy males and females * age 18-70 * BMI range 18,5-30,0 kg/m2 2. Patients with CKD * age 18-70 * eGFR 15-60 ml/min * BMI range 18.5 - 30.0 kg/m2

Exclusion criteria

1. healthy subjects * 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 2. Patients with chronic kidney disease * clinical significant signs of heart, lung, liver, endocrine, brain or neoplastic disease. * diabetes * immunosuppressive medications * smoking * alcohol abuse * drug abuse * pregnancy or nursing

Design outcomes

Primary

MeasureTime frameDescription
urinary biomarkersone dayUrinary epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion

Secondary

MeasureTime frameDescription
vaso active hormonesone dayplasma concentrations of: renin, Angiotensin II, aldosterone, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
extra-and intracellular volume6 hoursmeasured by body composition monitor at baseline and after intervention

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026