The effect of furosemide on fluid volumesand biomarkers in urine for measurement of sodium and water channel activity in healthy subjects

Phase 1

Active, not recruiting

• Conditions: healthy people; MedDRA version: 14.1Level: LLTClassification code 10049506Term: Investigation NOSSystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2012-003815-71-DK
• Lead Sponsor: Department of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-04
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy volunteer men and women.
Age 18 - 45 years.
BMI within the normal range, ie. between 18.5 to 30.0 kg/m2
Fertil women  must use effective contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Arterial hypertension, ie. ambulatory blood pressure> 130 mmHg systolic and / or 80 mmHg diastolic.
A history or clinical evidence of significant cardiac, pulmonary, hepato, renal, endocrine, cerebral and neoplastic disorders.
Alcohol and Substance Abuse.
Medical treatment apart from oral contraceptives.
Smoking.
Pregnancy or breast-feeding.
Lack of desire to participate.
Blood Donation within the last month
abnormal blood tests
Allergy above one of the ingredients of the study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose is to measure the effect of intravenous furosemide administration on changes in volume status via whole body bioimpedance spectroscopy (ICV, ECV, TBV, ECV / ICV);Secondary Objective: The purpose is to measure the effect of intravenous furosemide administration on renal treatment of sodium and water ( u-AQP2, u-ENAC, u-NCC, u-NKCC2, GFR, CH2O, FENA; plasma concentrations of vasoactive hormones (PRC, p-Ang II, p-ALDO, p-AVP, p-ANP and BNP p); central blood pressure (CBT), endothelbundet glycokalyx (p-syndecan-1);Primary end point(s): Extracellular volumen ECV;Timepoint(s) of evaluation of this end point: end of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Intracellular volume( ICV), total body water( TBW), central BP, arteriel stiffness( Pulse wave velocity), plasma concentrations of angiotensin II, aldosteron, vasopressin, syndecan, P-ANP og P-BNP, free water clearance ( CH2O), GFR, protein excretion from epithelial sodium channels ( u- EnaC, u-NKCC, u-NCC) and aquaporins(u-AQP2), fractional excretion of sodium ( FENa);Timepoint(s) of evaluation of this end point: end of study