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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-04-29

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.

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Detailed Description

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Conditions

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Acute Heart Failure Congestion Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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0.9 % Sodium Chloride solution

Patients receiving an intravenous infusion of 0.9% NaCl

Group Type EXPERIMENTAL

Furosemide intravenous infusion

Intervention Type 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.

Continous intravenous infusion of 0.9% Sodium Chloride solution

Intervention Type DRUG

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

5% Glucose solution

Patients receiving an intravenous infusion of 5% glucose

Group Type ACTIVE_COMPARATOR

Furosemide intravenous infusion

Intervention Type 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.

Continous intravenous infusion of 5% Glucose solution

Intervention Type DRUG

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

Interventions

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Furosemide 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.

Intervention Type DRUG

Continous 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

Intervention Type DRUG

Continous intravenous infusion of 5% Glucose solution

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

Intervention Type DRUG

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