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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days following randomization

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~170

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