Effect of Hypertonic Sodium Chloride on Urinary Biomarkers in Healthy Subjects and Patients With Chronic Kidney Disease
CASE
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
1 other identifier
interventional
47
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 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
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 4, 2014
March 1, 2014
1.3 years
June 18, 2012
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
urinary biomarkers
Urinary epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion
one day
Secondary Outcomes (2)
vaso active hormones
one day
extra-and intracellular volume
6 hours
Study Arms (1)
hypertonic saline
OTHERhypertonic saline 3.0% (7 ml/kg)
Interventions
hypertonic saline 3.0 % (7 ml/kg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Research
Holstebro, 7500, Denmark
Related Publications (1)
Jensen JM, Mose FH, Kulik AE, Bech JN, Fenton RA, Pedersen EB. Abnormal urinary excretion of NKCC2 and AQP2 in response to hypertonic saline in chronic kidney disease: an intervention study in patients with chronic kidney disease and healthy controls. BMC Nephrol. 2014 Jun 26;15:101. doi: 10.1186/1471-2369-15-101.
PMID: 24970686DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Erling B Pedersen, DMSc
Regional Hospital Holstebro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DMSc
Study Record Dates
First Submitted
June 18, 2012
First Posted
June 20, 2012
Study Start
December 1, 2011
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
March 4, 2014
Record last verified: 2014-03