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

Sponsor

Wroclaw Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05962255

Collaborator

(none)

Enrollment

Location

Arms

26.9

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure Congestion Heart Failure	Drug: Furosemide intravenous infusion Drug: Continous intravenous infusion of 0.9% Sodium Chloride solution Drug: Continous intravenous infusion of 5% Glucose solution	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.9 % Sodium Chloride solution Patients receiving an intravenous infusion of 0.9% NaCl	Drug: 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. 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
Active Comparator: 5% Glucose solution Patients receiving an intravenous infusion of 5% glucose	Drug: 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. 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

Arm

Intervention/Treatment

Experimental: 0.9 % Sodium Chloride solution

Patients receiving an intravenous infusion of 0.9% NaCl

Drug: 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.

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

Active Comparator: 5% Glucose solution

Patients receiving an intravenous infusion of 5% glucose

Drug: Furosemide intravenous infusion

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

Outcome Measures

Primary Outcome Measures

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.
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.
Total dose of furosemide. [48 hours]
Comparison of the total dose of furosemide between the groups at hours.

Secondary Outcome Measures

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.
Renin-Angiotensin-Aldosterone system activity. [48 hours]
Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.
Heart Failure rehospitalization [30 days]
Compare the need for Heart Failure rehospitalization within 30 days.

Other Outcome Measures

Body weight [24 hours]
Body weight change after the first day of the procedure.
Body weight [48 hours]
Body weight change after the second day of the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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