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Diuretic

Active deresuscitation for Sepsis (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

RADAR-Canada Trial 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.Check my eligibility

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.See study design

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.

RADAR-Canada Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of protocol

Compliance with deresuscitation protocol

Efficacy: Mean cumulative fluid balance

Secondary outcome measures

All cause mortality

New onset organ dysfunction

Organ support-free days

Other outcome measures

Inflammatory and renal biomarkers - change from baseline values

RADAR-Canada 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

540 Previous Clinical Trials

447,660 Total Patients Enrolled

2 Trials studying Sepsis

400 Patients Enrolled for Sepsis

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,394 Total Patients Enrolled

9 Trials studying Sepsis

6,660 Patients Enrolled for Sepsis

John C Marshall, MDPrincipal InvestigatorUnity Health Toronto

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial actively seeking participants at the moment?

"As per the information on clinicaltrials.gov, this particular investigation is presently not seeking subjects. The trial was originally listed on May 1st, 2024 and most recently revised on March 16th, 2024. Despite its current inactivity, there are currently 492 other trials open for enrollment at present."

Answered by AI

What is the safety profile of Active deresuscitation in clinical practice?

"With this being a Phase 2 trial lacking efficacy data but having some safety information, our team rates the safety of Active deresuscitation at level 2."

Answered by AI

Do I meet the necessary qualifications to be enrolled in this research trial?

"To be considered for this research project, potential participants must have a severe medical condition and fall within the age range of 18 to 120 years old. The study aims to enroll approximately 120 individuals."

Answered by AI

Could individuals aged 50 and above participate in this research study?

"Individuals aged between 18 and 120 are eligible for enrollment in this research. Notably, there are a total of 88 trials designated for those under 18 years old and 421 trials tailored to participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of Active Deresuscitation After Resuscitation:

John Marshall 2024. "Role of Active Deresuscitation After Resuscitation:". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06326112.

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