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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Heart Failure, Congestion, Heart Failure

Intervention / Treatment
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* Drug: Furosemide intravenous infusion
* Drug: Continous intravenous infusion of 0.9% Sodium Chloride solution
* Drug: Continous intravenous infusion of 5% Glucose solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.9 % Sodium Chloride solution<br>Patients receiving an intravenous infusion of 0.9% NaCl | Drug: Furosemide intravenous infusion<br>* 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.<br>Drug: Continous intravenous infusion of 0.9% Sodium Chloride solution<br>* Continuous 48h infusion of 0.9% sodium chloride at a fixed rate v= 83 ml/h x 24h = 2l/24h<br>|
| Active Comparator: 5% Glucose solution<br>Patients receiving an intravenous infusion of 5% glucose | Drug: Furosemide intravenous infusion<br>* 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.<br>Drug: Continous intravenous infusion of 5% Glucose solution<br>* Continuous 48h infusion of 5% Glucose at a fixed rate v= 83 ml/h x 24h = 2l/24h<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute heart failure, decongestion, volume replacement, sodium chloride, congestion