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Diuretic

Fluid Removal Protocol for Fluid Overload (RADAR-Canada Trial)

Phase 2
Waitlist Available
Led By John C Marshall, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days following randomization
Awards & highlights

Summary

This trial is testing a new protocol to remove excess fluid from patients in the ICU. The goal is to see if patients will follow the protocol and if it will have any impact on their health.

Who is the study for?
This trial is for ICU patients who still have too much fluid in their body after initial treatment. It's not clear what the specific inclusion or exclusion criteria are, but typically, participants would need to be stable enough for additional interventions and without conditions that could skew results.
What is being tested?
The RADAR-Canada trial is testing a protocol using Furosemide (a diuretic injection) and Metolazone (diuretic tablets) to see if they can help remove excess fluid from patients more quickly than usual care.
What are the potential side effects?
Possible side effects of Furosemide and Metolazone include dehydration, electrolyte imbalances like low potassium or sodium, dizziness, headaches, increased urination, and potentially kidney issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days following randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days following randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of protocol
Compliance with deresuscitation protocol
Efficacy: Mean cumulative fluid balance
Secondary study objectives
All cause mortality
New onset organ dysfunction
Organ support-free days
Other study objectives
Inflammatory and renal biomarkers - change from baseline values

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active deresuscitationExperimental Treatment2 Interventions
* Fluid minimization: clinical and research teams will review all intravenous orders and attempt to reduce fluids to 10-15 ml/hr. * Active deresuscitation: * Administer bolus furosemide 0.5 mg/kg bid or tid * Target daily negative fluid balance as follows: Calculated positive balance: \< 3 liters -600 - -800 ml/24 hours 3-6 liters 0.8 - 1.2 liters/24 hours 6- 10 liters 1.2 - 2.0 liters/24 hours \>10 liters \>2.0 liters/24 hours * If bolus furosemide fails to achieve these goals, results in hypotension or tachycardia, or at the discretion of the attending intensivist, start furosemide infusion titrated on an hourly basis to achieve above goals * If single agent ineffective, consider addition of metolazone
Group II: Usual careActive Control1 Intervention
Care at the discretion of the attending team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Furosemide Injection
2023
Completed Phase 3
~120

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
554 Previous Clinical Trials
454,171 Total Patients Enrolled
2 Trials studying Sepsis
400 Patients Enrolled for Sepsis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,519,122 Total Patients Enrolled
10 Trials studying Sepsis
9,160 Patients Enrolled for Sepsis
John C Marshall, MDPrincipal InvestigatorUnity Health Toronto
1 Previous Clinical Trials
80 Total Patients Enrolled
~72 spots leftby Mar 2025
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