Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE December 15, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
Diuresis [ Time Frame: 5 days ]
ml of diuresis
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Diuresis [ Time Frame: 5 days ]
Change History Complete list of historical versions of study NCT03750136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2019)
  • Length of hospitalisation [ Time Frame: 14 days ]
    days
  • BNP levels [ Time Frame: 5 days ]
    pg/ml
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Length of hospitalisation [ Time Frame: 14 days ]
  • BNP levels [ Time Frame: 5 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Furosemide Alone or Unexpectedly With Solution of Hypertonic Saline in Nephrotic Syndrome
Official Title  ICMJE HSS (Hypertonic Saline Solution) Plus High Dose Furosemide vs High Dose Furosemide in Nephrotic Syndrome - a Randomized Trial
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nephrotic Syndrome
Intervention  ICMJE
  • Drug: Hypertonic saline
    high dose furosemide with hypertonic saline 3x daily
  • Drug: Furosemide Injection
    high dose furosemide
Study Arms  ICMJE
  • Experimental: high-dose furosemide & hypertonic saline
    furosemide i.v., 3% NaCl
    Interventions:
    • Drug: Hypertonic saline
    • Drug: Furosemide Injection
  • Active Comparator: high-dose furosemide
    furosemide i.v.
    Intervention: Drug: Furosemide Injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alicja Rydzewska-Rosolowska, MD +48858317885 alicja.rosolowska@umb.edu.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03750136
Other Study ID Numbers  ICMJE IIKNT-001/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alicja Rydzewska-Rosołowska, Medical University of Bialystok
Study Sponsor  ICMJE Medical University of Bialystok
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicja Rydzewska-Rosolowska, MD Medical University of Białystok
PRS Account Medical University of Bialystok
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP