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Completed

NCT Number: NCT05962255

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

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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Key information

Conditions

Acute Heart Failure Cardiovascular Diseases Congestion Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Furosemide intravenous infusion

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

Drug

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 solution

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Cumulative urine output at 24 hours.

    Time frame: 24 hours

    Comparison of cumulative urine output between the groups at 24 hours.

  5. Cumulative urine output at hours.

    Time frame: 48 hours

    Comparison of cumulative urine output between the groups at 48 hours.

  6. Total dose of furosemide.

    Time frame: 48 hours

    Comparison of the total dose of furosemide between the groups at hours.

Secondary outcomes

  1. Total time on intravenous furosemide.

    Time frame: 3 months

    The total time on intravenous furosemide between hospital admission and discharge will be calculated.

  2. Renin-Angiotensin-Aldosterone system activity.

    Time frame: 24 hours

    Comparison of the renin and aldosterone serum levels between the groups at the 24 hours.

  3. Renin-Angiotensin-Aldosterone system activity.

    Time frame: 48 hours

    Comparison of the renin and aldosterone serum levels between the groups at the 48 hours.

  4. Heart Failure rehospitalization

    Time frame: 30 days

    Compare the need for Heart Failure rehospitalization within 30 days.

Other outcomes

  1. Body weight

    Time frame: 24 hours

    Body weight change after the first day of the procedure.

  2. Body weight

    Time frame: 48 hours

    Body weight change after the second day of the procedure.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study 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

Acronym: SOLVRED-AHF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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