Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure

Phase 3

Completed

• Conditions: Acute Heart Failure; Heart Failure; Congestion
• Interventions: Drug: Furosemide intravenous infusion; Drug: Continous intravenous infusion of 0.9% Sodium Chloride solution; Drug: Continous intravenous infusion of 5% Glucose solution

• Registration Number: NCT05962255
• Lead Sponsor: Wroclaw Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2023-06-24
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-07-27
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9 % Sodium Chloride solution	Furosemide intravenous infusion	Patients receiving an intravenous infusion of 0.9% NaCl
0.9 % Sodium Chloride solution	Continous intravenous infusion of 0.9% Sodium Chloride solution	Patients receiving an intravenous infusion of 0.9% NaCl
5% Glucose solution	Furosemide intravenous infusion	Patients receiving an intravenous infusion of 5% glucose
5% Glucose solution	Continous intravenous infusion of 5% Glucose solution	Patients receiving an intravenous infusion of 5% glucose

Primary Outcome Measures

Name	Time	Method
Urine volume change at individual timepoints during second day of the procedure.	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.	24 hours	Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.
Total dose of furosemide.	48 hours	Comparison of the total dose of furosemide between the groups at hours.
Urine composition at individual time points.	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.	24 hours	Comparison of cumulative urine output between the groups at 24 hours.
Cumulative urine output at hours.	48 hours	Comparison of cumulative urine output between the groups at 48 hours.

Secondary Outcome Measures

Name	Time	Method
Total time on intravenous furosemide.	3 months	The total time on intravenous furosemide between hospital admission and discharge will be calculated.
Renin-Angiotensin-Aldosterone system activity.	48 hours	Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.
Heart Failure rehospitalization	30 days	Compare the need for Heart Failure rehospitalization within 30 days.

Trial Locations

Locations (1)

Institute of Heart Diseases, Wroclaw Medical University; 🇵🇱 Wroclaw, Lower Silesia, Poland