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

Primary Purpose

Acute Heart Failure, Congestion, Heart Failure

Status
Recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Furosemide intravenous infusion
Continous intravenous infusion of 0.9% Sodium Chloride solution
Continous intravenous infusion of 5% Glucose solution
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring acute heart failure, decongestion, volume replacement, sodium chloride, congestion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Heart Diseases, Wroclaw Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

0.9 % Sodium Chloride solution

5% Glucose solution

Arm Description

Patients receiving an intravenous infusion of 0.9% NaCl

Patients receiving an intravenous infusion of 5% glucose

Outcomes

Primary Outcome Measures

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.
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.
Urine composition at individual time points.
Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h
Cumulative urine output at 24 hours.
Comparison of cumulative urine output between the groups at 24 hours.
Cumulative urine output at hours.
Comparison of cumulative urine output between the groups at 48 hours.
Total dose of furosemide.
Comparison of the total dose of furosemide between the groups at hours.

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2023
Last Updated
July 23, 2023
Sponsor
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05962255
Brief Title
Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Congestion, Heart Failure
Keywords
acute heart failure, decongestion, volume replacement, sodium chloride, congestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.9 % Sodium Chloride solution
Arm Type
Experimental
Arm Description
Patients receiving an intravenous infusion of 0.9% NaCl
Arm Title
5% Glucose solution
Arm Type
Active Comparator
Arm Description
Patients receiving an intravenous infusion of 5% glucose
Intervention Type
Drug
Intervention Name(s)
Furosemide intravenous infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Continous intravenous infusion of 0.9% Sodium Chloride solution
Intervention Description
Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h
Intervention Type
Drug
Intervention Name(s)
Continous intravenous infusion of 5% Glucose solution
Intervention Description
Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h
Primary Outcome Measure Information:
Title
Urine volume change at individual timepoints during first day of the procedure.
Description
Comparison of urine volume between the groups at individual timepoints during the first day of the procedure.
Time Frame
24 hours
Title
Urine volume change at individual timepoints during second day of the procedure.
Description
Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.
Time Frame
48 hours
Title
Urine composition at individual time points.
Description
Comparison of urine composition (urinary sodium and urinary chloride) between the groups and its change during 72h
Time Frame
72 hours
Title
Cumulative urine output at 24 hours.
Description
Comparison of cumulative urine output between the groups at 24 hours.
Time Frame
24 hours
Title
Cumulative urine output at hours.
Description
Comparison of cumulative urine output between the groups at 48 hours.
Time Frame
48 hours
Title
Total dose of furosemide.
Description
Comparison of the total dose of furosemide between the groups at hours.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Total time on intravenous furosemide.
Description
The total time on intravenous furosemide between hospital admission and discharge will be calculated.
Time Frame
3 months
Title
Renin-Angiotensin-Aldosterone system activity.
Description
Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.
Time Frame
24 hours
Title
Renin-Angiotensin-Aldosterone system activity.
Description
Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.
Time Frame
48 hours
Title
Heart Failure rehospitalization
Description
Compare the need for Heart Failure rehospitalization within 30 days.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Body weight
Description
Body weight change after the first day of the procedure.
Time Frame
24 hours
Title
Body weight
Description
Body weight change after the second day of the procedure.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Biegus, MD, Ph. D.
Phone
71 736 42 05
Ext
+48
Email
jan.biegus@umw.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Gracjan Iwanek, MD
Phone
507046860
Ext
+48
Email
gracjan.iwanek@student.umw.edu.pl
Facility Information:
Facility Name
Institute of Heart Diseases, Wroclaw Medical University
City
Wroclaw
State/Province
Lower Silesia
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Biegus, MD, Ph. D.
Phone
71 736 42 05
Ext
+48
Email
jan.biegus@umw.edu.pl
First Name & Middle Initial & Last Name & Degree
Gracjan Iwanek, MD
Phone
507046860
Ext
+48
Email
gracjan.iwanek@student.umw.edu.pl
First Name & Middle Initial & Last Name & Degree
Gracjan Iwanek, MD
First Name & Middle Initial & Last Name & Degree
Szymon Urban, MD
First Name & Middle Initial & Last Name & Degree
Mateusz Guzik, MD
First Name & Middle Initial & Last Name & Degree
Robert Zymliński, MD, Ph. D.
First Name & Middle Initial & Last Name & Degree
Jeffrey Testani, MD, MTR
First Name & Middle Initial & Last Name & Degree
Piotr Ponikowski, MD, Profesor of Medicine
First Name & Middle Initial & Last Name & Degree
Jan Biegus, MD, Ph. D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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