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

Sponsor
Regional Hospital Holstebro (Other)
Overall Status
Completed
CT.gov ID
NCT01623661
Collaborator
(none)
47
Enrollment
1
Location
1
Arm
18
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hypertonic saline
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: hypertonic saline

hypertonic saline 3.0% (7 ml/kg)

Other: hypertonic saline
hypertonic saline 3.0 % (7 ml/kg)
Other Names:
  • hypertonic NaCl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. urinary biomarkers [one day]

      Urinary epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion

    Secondary Outcome Measures

    1. vaso active hormones [one day]

      plasma concentrations of: renin, Angiotensin II, aldosterone, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)

    2. extra-and intracellular volume [6 hours]

      measured by body composition monitor at baseline and after intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. healthy subjects

    • healthy males and females

    • age 18-70

    • BMI range 18,5-30,0 kg/m2

    1. 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Research Holstebro Denmark 7500

    Sponsors and Collaborators

    • Regional Hospital Holstebro

    Investigators

    • Study Director: Erling B Pedersen, DMSc, Regional Hospital Holstebro

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erling Bjerregaard Pedersen, DMSc, Regional Hospital Holstebro
    ClinicalTrials.gov Identifier:
    NCT01623661
    Other Study ID Numbers:
    • EBP-JMJ-2012-2
    First Posted:
    Jun 20, 2012
    Last Update Posted:
    Mar 4, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Erling Bjerregaard Pedersen, DMSc, Regional Hospital Holstebro
    Nephrology
    chronic kidney disease
    sodium-channels
    water-channels
    BCM
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Mar 4, 2014