NCT05298098

Brief Summary

Acute decompensated heart failure (HF) is one of the most common cardiologic issues in emergency departments. Loop diuretics have long been recognized as the key for the treatment of Acute Decompensated Heart Failure (ADHF).However, chronic treatment with diuretics may limit their response and deteriorates the renal function. The hypertonic saline solution (HSS) has been proposed in recent years as an adjunctive therapy for intravenous loop diuretics to improve or restore their initial pharmacological efficacy. In this study the investigators will evaluate the effectiveness of HSS as an adjunct to i.v. furosemide in patients admitted for AHF with renal dysfunction

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

5.2 years

First QC Date

January 17, 2022

Last Update Submit

May 13, 2023

Conditions

Acute Decompensated Heart Failure

Keywords

Hypertonic Saline SolutionRenal DysfunctionDiuretic

Outcome Measures

Primary Outcomes (4)

  • Length of Hospital Stay

    The period during which the patient is hospitalized

    1 week

  • In-hospital mortality

    Death occuring during hospitalization

    1 week

  • Renal Function Impairement

    Deterioration of renal function during hospital stay

    1 week

  • Need for inotropic drugs

    Hemodynamic instability requiring the introduction of inotropic drugs

    1 week

Secondary Outcomes (3)

  • 30 day Mortality

    30 days

  • Need for Renal Replacement Therapy

    1 week

  • Hospital Readmission

    30 days

Study Arms (2)

Hypertonic Saline Solution

ACTIVE COMPARATOR

50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour

Drug: Hypertonic Saline Solution

5% Dextrose solution

PLACEBO COMPARATOR

50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour

Drug: Placebo

Interventions

Hypertonic Saline SolutionDRUG

Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.

Also known as: Hypertonic Saline
Hypertonic Saline Solution
PlaceboDRUG

Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day.

5% Dextrose solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with 18 years of age or older
  • ADHF with congestive symptoms, laboratory(BNP) and echocardiographic criteria
  • NYHA ≥II(New York Heart Association functional classification)
  • Creatinine clearance≤60ml/mn (MDRD) or level of creatinine \>150 µg/ml)
  • BNP levels on admission ≥400 pg/mL

You may not qualify if:

  • age \< 18 years
  • NYHA class \< II
  • Patients with acute coronary syndrome, pulmonary thromboembolism, cardiac tamponade, pericarditis, those on dialysis; patients with chronic liver disease, pleuropneumonia, cerebral vascular disease, cancer, uncompensated diabetes, patients requiring pacemaker and concomitant other important comorbidity
  • Signs of hemodynamic instability, respiratory distress, coma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Semir Nouira, Professor

    University of Monastir

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Semir Nouira, Professor

CONTACT

73106046semir.nouira@rns.tn

Khaoula Bel Haj Ali, MD

CONTACT

7310600belhajalikhaoula@yahoo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The present study is a single-center, randomized, double-blind, placebo-controlled trial performed in a tertiary hospital. It designed to evaluate the effects of the administration of hypertonic saline solution (NaCl 10%) + furosemide to patients with decompensated heart failure. Population: This study will include adult patients admitted in the emergency department for ADHF
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

March 28, 2022

Study Start

July 1, 2018

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

TU(1)