Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2025-12-24 @ 11:49 AM
Study NCT ID:
NCT01623661
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2012-06-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Hypertonic Sodium Chloride on Urinary Biomarkers in Healthy Subjects and Patients With Chronic Kidney Disease
Sponsor:
Regional Hospital Holstebro
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASE
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: