Acute Heart Failure, Congestion, Heart Failure
Conditions
Keywords
acute heart failure, decongestion, volume replacement, sodium chloride, congestion
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.
Interventions
DRUGFurosemide 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.
DRUGContinous 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
DRUGContinous intravenous infusion of 5% Glucose solution
Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h
Sponsors
Wroclaw Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of furosemide. | 48 hours | Comparison of the total dose of furosemide between the groups at hours. |
| Urine volume change at individual timepoints during second day of the procedure. | 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. | 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. | 24 hours | Comparison of cumulative urine output between the groups at 24 hours. |
| Cumulative urine output at hours. | 48 hours | Comparison of cumulative urine output between the groups at 48 hours. |
| Urine volume change at individual timepoints during first day of the procedure. | 24 hours | Comparison of urine volume between the groups at individual timepoints during the first day of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total time on intravenous furosemide. | 3 months | The total time on intravenous furosemide between hospital admission and discharge will be calculated. |
| Renin-Angiotensin-Aldosterone system activity. | 24 hours | Comparison of the renin and aldosterone serum levels between the groups at the 24 hours. |
| Heart Failure rehospitalization | 30 days | Compare the need for Heart Failure rehospitalization within 30 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 24 hours | Body weight change after the first day of the procedure. |
Countries
Poland
Outcome results
None listed