Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure (SOLVRED-AHF)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acute Heart Failure; Congestion
• Intervention / Treatment: Drug: Furosemide intravenous infusion; Drug: Continous intravenous infusion of 0.9% Sodium Chloride solution; Drug: Continous intravenous infusion of 5% Glucose solution

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Lower Silesia
    • Wroclaw, Lower Silesia, Poland, 50-556
      • Institute of Heart Diseases, Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.9 % Sodium Chloride solution; Patients receiving an intravenous infusion of 0.9% NaCl	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.; Drug: 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
Active Comparator: 5% Glucose solution; Patients receiving an intravenous infusion of 5% glucose	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.; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Cumulative urine output at 24 hours.	Comparison of cumulative urine output between the groups at 24 hours.	24 hours
Cumulative urine output at hours.	Comparison of cumulative urine output between the groups at 48 hours.	48 hours
Total dose of furosemide.	Comparison of the total dose of furosemide between the groups at hours.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time on intravenous furosemide.	The total time on intravenous furosemide between hospital admission and discharge will be calculated.	3 months
Renin-Angiotensin-Aldosterone system activity.	Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.	24 hours
Renin-Angiotensin-Aldosterone system activity.	Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.	48 hours
Heart Failure rehospitalization	Compare the need for Heart Failure rehospitalization within 30 days.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight change after the first day of the procedure.	24 hours
Body weight	Body weight change after the second day of the procedure.	48 hours

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: acute heart failure; sodium chloride; decongestion; congestion; volume replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Pharmaceutical Solutions; Furosemide
• Other Study ID Numbers: KB-68/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No