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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003815-71-DK

Enrollment

Registered

2013-02-04

Start date

2013-02-08

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy people MedDRA version: 14.1 Level: LLT Classification code 10049506 Term: Investigation NOS System Organ Class: 100000004848

Interventions

Trade Name: Furix 10 mg/ml Product Name: furix Pharmaceutical Form: Injection INN or Proposed INN: FUROSEMIDE CAS Number: 54-31-9 Current Sponsor code: AK-1-2012 Concentration unit: mg/ml milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactDepartment of Medical Research

Holstebro Hospital

aocza@hotmail.com4578436589

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026