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Clinical Trials/NCT05962255
NCT05962255
Completed
Phase 3

The Impact of Slow, Continuous Infusion of Sodium Chloride or Glucose Solution on Diuresis and Urine Composition During Decongestion of Acute Heart Failure Patients

Wroclaw Medical University1 site in 1 country50 target enrollmentFebruary 1, 2022

Overview

Phase
Phase 3
Intervention
Furosemide intravenous infusion
Conditions
Acute Heart Failure
Sponsor
Wroclaw Medical University
Enrollment
50
Locations
1
Primary Endpoint
Urine volume change at individual timepoints during second day of the procedure.
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of the study is to compare the differences in diuretic, natriuretic and clinical response to decongestion in patients receiving different replacement fluid regimens (0.9% sodium chloride vs 5% glucose) in acute heart failure.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
April 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wroclaw Medical University
Responsible Party
Principal Investigator
Principal Investigator

Gracjan Iwanek

Medical Doctor

Wroclaw Medical University

Eligibility Criteria

Inclusion Criteria

  • patients \>18 years old who sign the informed consent
  • the primary cause of hospitalization is Acute Heart Failure with a need for intravenous Furosemide
  • the start of the study within 24h of hospital admission

Exclusion Criteria

  • need for inotropic support
  • end stage renal disease on dialysis
  • serum sodium \> 148mmol/l or \< 130 mmol/l.

Arms & Interventions

0.9 % Sodium Chloride solution

Patients receiving an intravenous infusion of 0.9% NaCl

Intervention: Furosemide intravenous infusion

0.9 % Sodium Chloride solution

Patients receiving an intravenous infusion of 0.9% NaCl

Intervention: Continous intravenous infusion of 0.9% Sodium Chloride solution

5% Glucose solution

Patients receiving an intravenous infusion of 5% glucose

Intervention: Furosemide intravenous infusion

5% Glucose solution

Patients receiving an intravenous infusion of 5% glucose

Intervention: Continous intravenous infusion of 5% Glucose solution

Outcomes

Primary Outcomes

Urine volume change at individual timepoints during second day of the procedure.

Time Frame: 48 hours

Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.

Urine volume change at individual timepoints during first day of the procedure.

Time Frame: 24 hours

Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.

Total dose of furosemide.

Time Frame: 48 hours

Comparison of the total dose of furosemide between the groups at hours.

Urine composition at individual time points.

Time Frame: 72 hours

Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h

Cumulative urine output at 24 hours.

Time Frame: 24 hours

Comparison of cumulative urine output between the groups at 24 hours.

Cumulative urine output at hours.

Time Frame: 48 hours

Comparison of cumulative urine output between the groups at 48 hours.

Secondary Outcomes

  • Total time on intravenous furosemide.(3 months)
  • Renin-Angiotensin-Aldosterone system activity.(48 hours)
  • Heart Failure rehospitalization(30 days)

Study Sites (1)

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