The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects
NARA
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 20, 2013
May 1, 2013
1 year
August 9, 2011
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
day one
Secondary Outcomes (1)
blood hormones regulating salt, water and blood pressure
day one
Study Arms (3)
glucose
PLACEBO COMPARATORglucose 5 %
isotonic saline
ACTIVE COMPARATORisotonic saline 0.9 mg/ml
hypertonic saline
ACTIVE COMPARATORhypertonic saline 2.9 mg/ml
Interventions
infusion, 23 ml/kg, during 50 minutes
infusion, 7 ml/kg, during 50 minutes
Eligibility Criteria
You may qualify if:
- healthy males and females
- age 18-45
- BMI range 18,5-30,0 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicinsk Forskning, Regionshospitalet i Holstebro
Holstebro, 7500, Denmark
Related Publications (1)
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.
PMID: 24067081DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Erling B Pedersen, Professor
Medicinsk Forskning, Regionshospitalet i Holstebro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DMSc
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 11, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 20, 2013
Record last verified: 2013-05