Effect of Hypertonic Sodium Chloride on Urinary Biomarkers in Healthy Subjects and Patients With Chronic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects

NCT01414088

Nephropathy

COMPLETED NA

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

NCT01635231

Nephropathy

COMPLETED NA

Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease

NCT06354842

Chronic Kidney Diseases

COMPLETED

Saline Infusion Test in Hyponatremia

NCT06498856

Hyponatremia

NOT_YET_RECRUITING

Effect of the Aquaretic Tolvaptan on Nitric Oxide System

NCT02527863

Autosomal Dominant Polycystic Kidney Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The fractional sodium excretion is elevated as high as 10-20% In patients with chronic kidney disease (CKD) Changes in the sodium intake results in a slower expansion and/or reduction in extracellular fluid in CKD patients.

Urinary biomarkers reflects the kidneys transport of sodium and water in the nephron.

Changes in the sodium-and water channel activity is induced by intervention with hypertonic Saline (3.0%) The change in sodium-and water channel activity is followed by change in extracellular and intracellular fluid compartments 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), the activity of the sodium-and water channels, the extra- and intracellular fluid compartments and the plasma concentration of Vasoactive hormones in patients with CKD and in healthy subjects.

Subjects and patients are examined during one examination day. Four days prior to the examination day the subjects consume a standardized diet based on the amount of sodium and calories. On the examination day 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) are measured to evaluate the activity of sodium channels in the nephron and changes in fluid compartments are measured by body composition monitor.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hypertonic saline

hypertonic saline 3.0% (7 ml/kg)

Group Type OTHER

hypertonic saline

Intervention Type OTHER

hypertonic saline 3.0 % (7 ml/kg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hypertonic saline

hypertonic saline 3.0 % (7 ml/kg)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

hypertonic NaCl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. healthy subjects

* healthy males and females
* age 18-70
* BMI range 18,5-30,0 kg/m2
2. Patients with CKD

* age 18-70
* eGFR 15-60 ml/min
* BMI range 18.5 - 30.0 kg/m2

Exclusion Criteria

1. 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
2. Patients with chronic kidney disease

* clinical significant signs of heart, lung, liver, endocrine, brain or neoplastic disease.
* diabetes
* immunosuppressive medications
* smoking
* alcohol abuse
* drug abuse
* pregnancy or nursing

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes