An interventional study of hypertonic saline in Nephropathy, sponsored by Regional Hospital Holstebro. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-04.
Sponsored by Regional Hospital Holstebro · Not applicable, Interventional, and Diagnostic
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.
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.
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This study's enrollment of 47 is below the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.
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healthy subjects
Patients with CKD
Exclusion Criteria:
healthy subjects
Patients with chronic kidney disease
hypertonic saline 3.0% (7 ml/kg)
Other: hypertonic saline
hypertonic saline 3.0 % (7 ml/kg)
Also known as: hypertonic NaCl
urinary biomarkers
Urinary epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion
Time frame: one day
vaso active hormones
plasma concentrations of: renin, Angiotensin II, aldosterone, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
Time frame: one day
extra-and intracellular volume
measured by body composition monitor at baseline and after intervention
Time frame: 6 hours
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Regional Hospital Holstebro