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

Heart Failure Clinical Trial

— SOLVRED-AHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962255
• Other study ID #: KB-68/2022
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Wroclaw Medical University
• Contact: Jan Biegus, MD, Ph. D.
• Phone: 71 736 42 05
• Email: jan.biegus[@]umw.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Congestion
• Heart Failure

Intervention

Drug:
• Furosemide intravenous infusion
At baseline, patients will receive a standardised dose of furosemide 1mg/kg (half of the dose administered as bolus and half as in 2h infusion). At the 6th and the 12th hour of the study patients will be reassessed and the need for additional diuretics.
• Continous intravenous infusion of 0.9% Sodium Chloride solution
Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h
• Continous intravenous infusion of 5% Glucose solution
Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h

Locations

Country	Name	City	State
Poland	Institute of Heart Diseases, Wroclaw Medical University	Wroclaw	Lower Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight	Body weight change after the first day of the procedure.	24 hours
Other	Body weight	Body weight change after the second day of the procedure.	48 hours
Primary	Urine volume change at individual timepoints during first day of the procedure.	Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.	24 hours
Primary	Urine volume change at individual timepoints during second day of the procedure.	Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.	48 hours
Primary	Urine composition at individual time points.	Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h	72 hours
Primary	Cumulative urine output at 24 hours.	Comparison of cumulative urine output between the groups at 24 hours.	24 hours
Primary	Cumulative urine output at hours.	Comparison of cumulative urine output between the groups at 48 hours.	48 hours
Primary	Total dose of furosemide.	Comparison of the total dose of furosemide between the groups at hours.	48 hours
Secondary	Total time on intravenous furosemide.	The total time on intravenous furosemide between hospital admission and discharge will be calculated.	3 months
Secondary	Renin-Angiotensin-Aldosterone system activity.	Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.	24 hours
Secondary	Renin-Angiotensin-Aldosterone system activity.	Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.	48 hours
Secondary	Heart Failure rehospitalization	Compare the need for Heart Failure rehospitalization within 30 days.	30 days