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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01414088
First received: August 9, 2011
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Nephropathy
 Drug: isotonic saline 0,9 mg/ml
Drug: hypertonic saline 2,9 mg/ml
Drug: glucose 5%

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Renal biomarkers [ Time Frame: day one ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • blood hormones regulating salt, water and blood pressure [ Time Frame: day one ] [ Designated as safety issue: No ]
    plasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)


Enrollment: 23
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: glucose Drug: glucose 5%
infusion, 23 ml/kg, during 50 minutes
Other Name: glucose 5 %
Active Comparator: isotonic saline Drug: isotonic saline 0,9 mg/ml
infusion, 23 ml/kg, during 50 minutes
Other Name: isotonic saline
Active Comparator: hypertonic saline Drug: hypertonic saline 2,9 mg/ml
infusion, 7 ml/kg, during 50 minutes
Other Name: hypertonic saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414088

Locations
Denmark
Medicinsk Forskning, Regionshospitalet i Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Director: Erling B Pedersen, Professor Medicinsk Forskning, Regionshospitalet i Holstebro
  More Information

No publications provided

Responsible Party: Erling Bjerregaard Pedersen, DMSc, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01414088     History of Changes
Other Study ID Numbers: EBP-JMJ-2011-1
Study First Received: August 9, 2011
Last Updated: June 18, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Regional Hospital Holstebro:
Nephrology
ENaC
NCC
 NKCC
Sodium channels
renal biomarkers

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013