NCT03750136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

November 20, 2018

Last Update Submit

November 19, 2022

Conditions

Nephrotic Syndrome

Keywords

diuretics

Outcome Measures

Primary Outcomes (1)

  • Diuresis

    ml of diuresis

    5 days

Secondary Outcomes (2)

  • Length of hospitalisation

    14 days

  • BNP levels

    5 days

Study Arms (2)

high-dose furosemide & hypertonic saline

EXPERIMENTAL

furosemide i.v., 3% NaCl

Drug: Hypertonic salineDrug: Furosemide Injection

high-dose furosemide

ACTIVE COMPARATOR

furosemide i.v.

Drug: Furosemide Injection

Interventions

Hypertonic salineDRUG

high dose furosemide with hypertonic saline 3x daily

Also known as: 3% saline
high-dose furosemide & hypertonic saline
Furosemide InjectionDRUG

high dose furosemide

high-dose furosemidehigh-dose furosemide & hypertonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

II Department of Nephrology and Hypertension

Bialystok, 15-276, Poland

RECRUITING

Related Publications (3)

  • Licata G, Di Pasquale P, Parrinello G, Cardinale A, Scandurra A, Follone G, Argano C, Tuttolomondo A, Paterna S. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as bolus in refractory congestive heart failure: long-term effects. Am Heart J. 2003 Mar;145(3):459-66. doi: 10.1067/mhj.2003.166.

    PMID: 12660669BACKGROUND

  • Paterna S, Parrinello G, Amato P, Dominguez L, Pinto A, Maniscalchi T, Cardinale A, Licata A, Amato V, Licata G, Di Pasquale P. Tolerability and efficacy of high-dose furosemide and small-volume hypertonic saline solution in refractory congestive heart failure. Adv Ther. 1999 Sep-Oct;16(5):219-28.

    PMID: 10915397BACKGROUND

  • Paterna S, Di Pasquale P, Parrinello G, Amato P, Cardinale A, Follone G, Giubilato A, Licata G. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as a bolus, in refractory congestive heart failure. Eur J Heart Fail. 2000 Sep;2(3):305-13. doi: 10.1016/s1388-9842(00)00094-5.

    PMID: 10938493BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Saline Solution, HypertonicSodium ChlorideFurosemide

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsSulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Alicja Rydzewska-Rosolowska, MD

    Medical University of Białystok

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicja Rydzewska-Rosolowska, MD

CONTACT

+48858317885alicja.rosolowska@umb.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

December 15, 2018

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

PL(1)