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Completed

NCT Number: NCT01414088

The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects

The kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. We do not know how these channels work in certain water and sodium accumulating medical conditions.

The purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicinsk Forskning, Regionshospitalet i Holstebro

Holstebro, 7500, Denmark

About this study

25 healthy subjects from age 18-45 are recruited.

Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories.

On the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes.

Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and creatinine.

Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in the nephron.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy males and females
  • age 18-45
  • BMI range 18,5-30,0 kg/m2

Exclusion criteria

  • 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

Treatment and study plan

isotonic saline 0,9 mg/ml

Other

infusion, 23 ml/kg, during 50 minutes

Other names: isotonic saline

hypertonic saline 2,9 mg/ml

Other

infusion, 7 ml/kg, during 50 minutes

Other names: hypertonic saline

Glucose 5%

Other

infusion, 23 ml/kg, during 50 minutes

Other names: glucose 5 %

Primary outcomes

  1. Renal biomarkers

    Time frame: day one

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

Secondary outcomes

  1. blood hormones regulating salt, water and blood pressure

    Time frame: day one

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

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers for the Measurement of Sodium and Water Channel Activity in the Nephron in Healthy Young Subjects

Acronym: NARA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
May 20, 2013

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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