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

NCT05962255 | Completed Phase 3

• 1 other identifier: KB-68/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure; Congestion; Heart Failure

Keywords

acute heart failure; decongestion; volume replacement; sodium chloride; congestion

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Total time on intravenous furosemide.

  3 months

• Renin-Angiotensin-Aldosterone system activity.

  24 hours

• Renin-Angiotensin-Aldosterone system activity.

  48 hours

• Heart Failure rehospitalization

  30 days

Other Outcomes (2)

• Body weight

  24 hours

• Body weight

  48 hours

Study Arms (2)

0.9 % Sodium Chloride solution

EXPERIMENTAL

Patients receiving an intravenous infusion of 0.9% NaCl

Drug: Furosemide intravenous infusion; Drug: Continous intravenous infusion of 0.9% Sodium Chloride solution

5% Glucose solution

ACTIVE COMPARATOR

Patients receiving an intravenous infusion of 5% glucose

Drug: Furosemide intravenous infusion; Drug: Continous intravenous infusion of 5% Glucose solution

Interventions

Furosemide intravenous infusion DRUG

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.

0.9 % Sodium Chloride solution; 5% Glucose solution

Continous intravenous infusion of 0.9% Sodium Chloride solution DRUG

Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h

0.9 % Sodium Chloride solution

Continous intravenous infusion of 5% Glucose solution DRUG

Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h

5% Glucose solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Related Publications (1)

• Biegus J, Iwanek G, Testani J, Zymlinski R, Fudim M, Guzik M, Gajewski P, Ponikowski P. Sodium chloride versus glucose solute as a volume replacement therapy for more effective decongestion in acute heart failure (SOLVRED-AHF): A prospective, randomized, mechanistic study. Eur J Heart Fail. 2025 Jun 2. doi: 10.1002/ejhf.3708. Online ahead of print.

  PMID: 40455066 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 27, 2023
• Study Start: February 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 29, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)