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NCT Number: NCT01623661

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

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.

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Key information

Conditions

Nephropathy Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research

Holstebro, 7500, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

hypertonic saline

Other

hypertonic saline 3.0 % (7 ml/kg)

Other names: hypertonic NaCl

Primary outcomes

  1. urinary biomarkers

    Time frame: one day

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

Secondary outcomes

  1. vaso active hormones

    Time frame: one day

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

  2. extra-and intracellular volume

    Time frame: 6 hours

    measured by body composition monitor at baseline and after intervention

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study 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

Acronym: CASE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2012
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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