NephropathyNARANCT01414088
The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects
A study testing isotonic saline 0,9 mg/ml, hypertonic saline 2,9 mg/ml and glucose 5% in people with Nephropathy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephropathy
- What is being tested?
- isotonic saline 0,9 mg/ml, hypertonic saline 2,9 mg/ml and glucose 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males and females
- age 18-45
- BMI range 18,5-30,0 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk Forskning, Regionshospitalet i Holstebro
Holstebro, 7500
About this study
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
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.
Read the 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.
- Conditions
- Nephropathy
- Being tested
- isotonic saline 0,9 mg/ml, hypertonic saline 2,9 mg/ml, glucose 5%
- Keywords
- Nephrology, ENaC, NCC, NKCC, Sodium channels, renal biomarkers
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotonic saline 0,9 mg/mlOther
Also called isotonic saline
infusion, 23 ml/kg, during 50 minutes
hypertonic saline 2,9 mg/mlOther
Also called hypertonic saline
infusion, 7 ml/kg, during 50 minutes
glucose 5%Other
Also called glucose 5 %
infusion, 23 ml/kg, during 50 minutes
| Study group | Role | What they receive |
|---|---|---|
| glucose | Placebo comparator | glucose 5 % Receives: Other: glucose 5% |
| isotonic saline | Active comparator | isotonic saline 0.9 mg/ml Receives: Other: isotonic saline 0,9 mg/ml |
| hypertonic saline | Active comparator | hypertonic saline 2.9 mg/ml Receives: Other: hypertonic saline 2,9 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day one
Secondary outcomes (1)
blood hormones regulating salt, water and blood pressure
plasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Erling B Pedersen, Professor, Study director, Medicinsk Forskning, Regionshospitalet i Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414088
- Sponsor's protocol ID
- EBP-JMJ-2011-1
- Acronym
- NARA
- Status last verified
- May 2013
- First submitted
- 9 Aug 2011
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24067081
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01414088
- Acronym / sponsor ID
- NARA / EBP-JMJ-2011-1
- Conditions
- Nephropathy
- Keywords
- Nephrology, ENaC, NCC, NKCC, Sodium channels, renal biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| glucose | Placebo comparator | Other: glucose 5%glucose 5 % |
| isotonic saline | Active comparator | Other: isotonic saline 0,9 mg/mlisotonic saline 0.9 mg/ml |
| hypertonic saline | Active comparator | Other: hypertonic saline 2,9 mg/mlhypertonic saline 2.9 mg/ml |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males and females
- age 18-45
- BMI range 18,5-30,0 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isotonic saline 0,9 mg/mlAlso: isotonic salineinfusion, 23 ml/kg, during 50 minutes | Other | isotonic saline |
| hypertonic saline 2,9 mg/mlAlso: hypertonic salineinfusion, 7 ml/kg, during 50 minutes | Other | hypertonic saline |
| glucose 5%Also: glucose 5 %infusion, 23 ml/kg, during 50 minutes | Other | glucose |
Primary outcome
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
1 secondary outcome
blood hormones regulating salt, water and blood pressure
Time frame: day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Derived from this study: PubMed 24067081Jensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B Pedersen, Professor study director
Medicinsk Forskning, Regionshospitalet i Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotonic saline 0,9 mg/ml, hypertonic saline 2,9 mg/ml and glucose 5% in people with Nephropathy, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal biomarkers (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.