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Furosemide Alone or Unexpectedly With Solution of Hypertonic Saline in Nephrotic Syndrome (FLUSH-NS)

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ClinicalTrials.gov Identifier: NCT03750136
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Alicja Rydzewska-Rosołowska, Medical University of Bialystok

Brief Summary:
The trial will test the hypothesis that hypertonic saline on top of standard diuretic treatment will help achieve adequate diuresis in patients with nephrotic syndrome.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Hypertonic saline Drug: Furosemide Injection Not Applicable

Detailed Description:

Objectives:

Edema is one of the major clinical manifestations of nephrotic syndrome. All patients are initially treated with diuretics and sodium restriction but the results are sometimes not satisfactory. Hypertonic saline solutions have been studied in congestive heart failure and a meta-analysis confirmed it's role in achieving adequate diuresis and protecting patients against acute kidney injury although the proposed mechanism of action is not known (osmotic action?, inhibition of renin-angiotensin-aldostrerone system?, increase in renal perfusion?, myocardial contractility?). The investigators therefore hypothesized that it may exert beneficial effects also in nephrotic syndrome.

Treatment protocol:

A prospective placebo-controlled randomized trial. Subjects will be randomized to high-dose furosemide vs high-dose furosemide plus hypertonic intravenous saline in a 1:1 fashion. All subjects will receive furosemide tid (starting with 3x40 mg i.v.) with or without hypertonic saline solution (3x100 ml of 3% NaCl - in a combined infusion lasting 10 minutes). Subjects randomized to furosemide only will receive 3x100 ml of 5% glucose (in a combined infusion lasting 10 minutes). The dose of furosemide will be determined by the investigator based on patients weight, severity of edema, 24-h urine volume, kidney function. In case of poor clinical response (urine volume below 1000 ml) the investigator will be able to titrate the furosemide dose up to 3x180 mg i.v. All patients will be kept on low-salt diet and water restriction (500-1000 ml/day), their weight will assessed every morning before breakfast and measurement of 24-h urine volume will be performed every day. Additionally BNP levels will be measured at baseline and after 5 days of treatment. Treatment will be continued for 5 days. The primary measure of efficacy will be urine volume and the rate of acute kidney injury (AKI), secondary measure of efficacy will be the expected decrease in brain natriuretic peptides (BNP) levels and the length of hospitalization.

Hydrochlorothiazide, spironolactone and other diuretics use will be contraindicated during the study. Patients will be required to receive standard concurrent therapy as determined by their attending physician and according to current guidelines (including steroids and other immunosuppresives).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: HSS (Hypertonic Saline Solution) Plus High Dose Furosemide vs High Dose Furosemide in Nephrotic Syndrome - a Randomized Trial
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: high-dose furosemide & hypertonic saline
furosemide i.v., 3% NaCl
Drug: Hypertonic saline
high dose furosemide with hypertonic saline 3x daily

Drug: Furosemide Injection
high dose furosemide

Active Comparator: high-dose furosemide
furosemide i.v.
Drug: Furosemide Injection
high dose furosemide




Primary Outcome Measures :
  1. Diuresis [ Time Frame: 5 days ]
    ml of diuresis


Secondary Outcome Measures :
  1. Length of hospitalisation [ Time Frame: 14 days ]
    days

  2. BNP levels [ Time Frame: 5 days ]
    pg/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30 consecutive patients with nephrotic syndrome (proteinuria over 3.5 g/day, edema, hypoalbuminemia, dysproteinemia) admitted to II Nephrology Department from November 2018 onwards within 48h of admission,
  • age above 18,
  • informed consent.

Exclusion Criteria:

  • AKI (acute kidney injury) - AKIN criteria level 3,
  • CKD (chronic kidney disease) stage 4 and 5 according to KDIGO (Kidney Disease: Improving Global Outcomes),
  • concomittant heart failure NYHA (New York Heart Association) class III or worse,
  • active liver disease and liver failure,
  • terminal neoplastic disease,
  • serum sodium above 145 mmol/l,
  • pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750136


Contacts
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Contact: Alicja Rydzewska-Rosolowska, MD +48858317885 alicja.rosolowska@umb.edu.pl

Locations
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Poland
II Department of Nephrology and Hypertension Recruiting
Bialystok, Poland, 15-276
Contact: Alicja Rydzewska-Rosolowska, MD    +48858317885    alicja.rosolowska@umb.edu.pl   
Sponsors and Collaborators
Medical University of Bialystok
Investigators
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Principal Investigator: Alicja Rydzewska-Rosolowska, MD Medical University of Białystok

Publications:
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Responsible Party: Alicja Rydzewska-Rosołowska, Principal Investigator, Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03750136     History of Changes
Other Study ID Numbers: IIKNT-001/2018
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alicja Rydzewska-Rosołowska, Medical University of Bialystok:
diuretics
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action