Acute Heart FailurePhase 3SOLVRED-AHFNCT05962255
Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure
A Phase 3 study testing Furosemide intravenous infusion, Continous intravenous infusion of 0.9% Sodium Chloride solution and Continous intravenous infusion of 5% Glucose solution in people with Acute Heart Failure and Congestion, run by Wroclaw Medical University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Congestion, Heart Failure
- What is being tested?
- Furosemide intravenous infusion, Continous intravenous infusion of 0.9% Sodium Chloride solution and Continous intravenous infusion of 5% Glucose solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2022to 29 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- need for inotropic support
- end stage renal disease on dialysis
- serum sodium > 148mmol/l or < 130 mmol/l.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
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
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
- Being tested
- Furosemide intravenous infusion, Continous intravenous infusion of 0.9% Sodium Chloride solution, Continous intravenous infusion of 5% Glucose solution
- Keywords
- acute heart failure, decongestion, volume replacement, sodium chloride, congestion
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide intravenous infusionDrug
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 solutionDrug
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 solutionDrug
Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h
| Study group | Role | What they receive |
|---|---|---|
| 0.9 % Sodium Chloride solution | Experimental | Patients receiving an intravenous infusion of 0.9% NaCl Receives: 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 Receives: Drug: Furosemide intravenous infusion; Drug: Continous intravenous infusion of 5% Glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 72 hours
Cumulative urine output at 24 hours.
Comparison of cumulative urine output between the groups at 24 hours.
Measured: 24 hours
Cumulative urine output at hours.
Comparison of cumulative urine output between the groups at 48 hours.
Measured: 48 hours
Total dose of furosemide.
Comparison of the total dose of furosemide between the groups at hours.
Measured: 48 hours
Secondary outcomes (4)
Total time on intravenous furosemide.
The total time on intravenous furosemide between hospital admission and discharge will be calculated.
Measured: 3 months
Renin-Angiotensin-Aldosterone system activity.
Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.
Measured: 24 hours
Renin-Angiotensin-Aldosterone system activity.
Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.
Measured: 48 hours
Heart Failure rehospitalization
Compare the need for Heart Failure rehospitalization within 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Feb 2022
- Primary completion1 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gracjan Iwanek, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962255
- Sponsor's protocol ID
- KB-68/2022
- Acronym
- SOLVRED-AHF
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Nov;27(11):2442-2451. doi: 10.1002/ejhf.3708. Epub 2025 Jun 2.
PubMed 40455066
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05962255
- Acronym / sponsor ID
- SOLVRED-AHF / KB-68/2022
- Conditions
- Acute Heart Failure, Congestion, Heart Failure
- Keywords
- acute heart failure, decongestion, volume replacement, sodium chloride, congestion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
| Arm | Type | Receives |
|---|---|---|
| 0.9 % Sodium Chloride solution | Experimental | Drug: Furosemide intravenous infusion, Drug: Continous intravenous infusion of 0.9% Sodium Chloride solutionPatients receiving an intravenous infusion of 0.9% NaCl |
| 5% Glucose solution | Active comparator | Drug: Furosemide intravenous infusion, Drug: Continous intravenous infusion of 5% Glucose solutionPatients receiving an intravenous infusion of 5% glucose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- need for inotropic support
- end stage renal disease on dialysis
- serum sodium > 148mmol/l or < 130 mmol/l.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide intravenous infusionAt 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 | 0.9 % Sodium Chloride solution, 5% Glucose solution |
| Continous intravenous infusion of 0.9% Sodium Chloride solutionContinuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h | Drug | 0.9 % Sodium Chloride solution |
| Continous intravenous infusion of 5% Glucose solutionContinuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h | Drug | 5% Glucose solution |
Primary outcome
Urine volume change at individual timepoints during first day of the procedure.
Time frame: 24 hours
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.
Time frame: 48 hours
Comparison of urine volume between the groups at individual timepoints during the second day of the procedure.
Urine composition at individual time points.
Time frame: 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.
Time frame: 24 hours
Comparison of cumulative urine output between the groups at 24 hours.
Cumulative urine output at hours.
Time frame: 48 hours
Comparison of cumulative urine output between the groups at 48 hours.
Total dose of furosemide.
Time frame: 48 hours
Comparison of the total dose of furosemide between the groups at hours.
4 secondary outcomes
Total time on intravenous furosemide.
Time frame: 3 months
Renin-Angiotensin-Aldosterone system activity.
Time frame: 24 hours
Renin-Angiotensin-Aldosterone system activity.
Time frame: 48 hours
Heart Failure rehospitalization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 40455066Biegus 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 Nov;27(11):2442-2451. doi: 10.1002/ejhf.3708. Epub 2025 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide intravenous infusion, Continous intravenous infusion of 0.9% Sodium Chloride solution and Continous intravenous infusion of 5% Glucose solution in people with Acute Heart Failure and Congestion, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine volume change at individual timepoints during first day of the procedure. (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.