The Effect of Thiazide, Amiloride and Hypertonic Saline o... | NCT01635231

Studies
The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects

NCT01635231

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Mar 4, 2014Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Nephropathy

Interventions

hypertonic saline

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jun 13, 2012

First Submission Date that Met QC Criteria

Jul 6, 2012

First Posted Date

Jul 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erling Bjerregaard Pedersen, Ph.d student Janni Majgaard Jensen, Regional Hospital HolstebroPrincipal Investigator

Lead Sponsor

Regional Hospital HolstebroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium- and water channels in the human kidney.

Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects

Detailed Description

Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the kidneys transport of sodium and water in the nephron.
Changes in the sodium-and water channel activity is induced by blocking the NCC channels with thiazide and ENaC channels with amiloride and by intervention with hypertonic NaCl The changes in sodium-and water channels are followed by changes in extracellular and intracellular fluids, central bloodpressure and the plasma concentration of vasoactive hormones.

The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), extra- and intracellular fluid compartments, central bloodpressure and the plasma concentration of Vasoactive hormones in healthy subjects under a) treatment with Amiloride and Thiazide at baseline and b) after and acute infusion with hypertonic saline.

Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on amount of sodium and calories and randomized to treatment with either thiazide, amiloride or placebo twice daily for 5 days. On the examination days the subjects receive an infusion with hypertonic saline.

Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) will be measured to evaluate the activity of water- and sodium channels in the nephron, changes in fluid compartments are measured by body composition monitor. Central blood pressure is measured by sphygmocor.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
thiazide, diuretic	Active Comparator	1.25 mg thiazide twice daily for 5 days	Other: hypertonic saline
amiloride, diuretic	Active Comparator	5 mg of amiloride twice daily	Other: hypertonic saline
calcium	Placebo Comparator	placebo twice daily for 5 days	Other: hypertonic saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hypertonic saline	Other	hypertonic saline 3.0% 7 ml/kg	amiloride, diuretic calcium thiazide, diuretic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urinary biomarkers	Urinary excretion of epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC2) and aquaporin2 channels (AQP2) before, during and after fluid infusion	baseline, 0 hours and 1.5 hours after intervention

Secondary Outcomes

Measure	Description	Time Frame
vaso active hormones	plasma concentrations of: renin, Angiotensin II, aldosterone, Vasopressin, ANP and BNP	baseline, 0 hours and 1.5 hours after intervention
central blood pressure	measured by applanation-tonometry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy males and females
age 18-45
BMI range 18,5-30,0 kg/m2

Exclusion Criteria:

hypertension (i.e. 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 abnormal blood samples, -ECG and -urine dipstick, drug abuse, alcohol abuse, pregnancy, medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, MD, DMSc	Medical Research, Holstebro	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research		Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012462	Saline Solution, Hypertonic

Ancestor Terms

ID	Term
D006982	Hypertonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided