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

Primary Purpose

Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
isotonic saline 0,9 mg/ml
hypertonic saline 2,9 mg/ml
glucose 5%
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nephropathy focused on measuring Nephrology, ENaC, NCC, NKCC, Sodium channels, renal biomarkers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medicinsk Forskning, Regionshospitalet i Holstebro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

glucose

isotonic saline

hypertonic saline

Arm Description

glucose 5 %

isotonic saline 0.9 mg/ml

hypertonic saline 2.9 mg/ml

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
August 9, 2011
Last Updated
May 17, 2013
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT01414088
Brief Title
The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects
Acronym
NARA
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy
Keywords
Nephrology, ENaC, NCC, NKCC, Sodium channels, renal biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glucose
Arm Type
Placebo Comparator
Arm Description
glucose 5 %
Arm Title
isotonic saline
Arm Type
Active Comparator
Arm Description
isotonic saline 0.9 mg/ml
Arm Title
hypertonic saline
Arm Type
Active Comparator
Arm Description
hypertonic saline 2.9 mg/ml
Intervention Type
Other
Intervention Name(s)
isotonic saline 0,9 mg/ml
Other Intervention Name(s)
isotonic saline
Intervention Description
infusion, 23 ml/kg, during 50 minutes
Intervention Type
Other
Intervention Name(s)
hypertonic saline 2,9 mg/ml
Other Intervention Name(s)
hypertonic saline
Intervention Description
infusion, 7 ml/kg, during 50 minutes
Intervention Type
Other
Intervention Name(s)
glucose 5%
Other Intervention Name(s)
glucose 5 %
Intervention Description
infusion, 23 ml/kg, during 50 minutes
Primary Outcome Measure Information:
Title
Renal biomarkers
Description
Urinary epithelial sodium channels (ENaC), Sodium-Chloride transporters (NCC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion
Time Frame
day one
Secondary Outcome Measure Information:
Title
blood hormones regulating salt, water and blood pressure
Description
plasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
Time Frame
day one

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling B Pedersen, Professor
Organizational Affiliation
Medicinsk Forskning, Regionshospitalet i Holstebro
Official's Role
Study Director
Facility Information:
Facility Name
Medicinsk Forskning, Regionshospitalet i Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24067081
Citation
Jensen JM, Mose FH, Bech JN, Nielsen S, Pedersen EB. Effect of volume expansion with hypertonic- and isotonic saline and isotonic glucose on sodium and water transport in the principal cells in the kidney. BMC Nephrol. 2013 Sep 26;14:202. doi: 10.1186/1471-2369-14-202.
Results Reference
derived

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

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