Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

120 Participants Needed

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

Overseen ByMichael Sklar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Unity Health Toronto

Disqualifiers: Dialysis, Brain injury, Cardiac failure, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of metolazone and furosemide safe for treating fluid overload?

The combination of metolazone and furosemide is generally effective for treating fluid overload, but it can cause serious side effects like severe electrolyte imbalances (problems with salt levels in the body). It's important to monitor patients closely to avoid these issues.¹ ² ³ ⁴ ⁵

How does the drug combination of furosemide and metolazone differ from other treatments for fluid overload?

The combination of furosemide and metolazone is unique because it effectively enhances diuresis (increased urine production) and natriuresis (increased sodium excretion) in patients who are resistant to furosemide alone. This combination allows for lower doses of furosemide, which can be beneficial for long-term therapy and in patients with reduced kidney function, potentially reducing side effects and treatment costs.¹ ² ³ ⁴ ⁶

What data supports the effectiveness of the drug combination of furosemide and metolazone for fluid overload?

Research shows that combining furosemide and metolazone is effective in increasing urine output and reducing fluid retention in patients with conditions like heart failure and edema, even when furosemide alone is not effective. This combination helps remove excess fluid from the body, leading to weight loss and improved symptoms.¹ ² ³ ⁶ ⁷

Who Is on the Research Team?

John C Marshall, MD

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have significant swelling in two or more areas or have accumulated over 3 liters of fluid since being in ICU.

I was in the ICU for 5 days or less.

Informed consent obtained from patient or alternate decision-maker

See 1 more

Exclusion Criteria

I have had a bleeding in the space around my brain.

Lack of consent from patient or substitute decision maker or from responsible physician

I had a severe brain injury with a low score on the coma scale.

See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are randomized to either usual care or a deresuscitation protocol incorporating a fluid minimization strategy and diuresis

1 week

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

Furosemide
Metolazone

Trial Overview 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.

How Is the Trial Designed?

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.

Furosemide is already approved in European Union, United States, Canada, Japan, China for the following indications: