Fluid Removal Protocol for Fluid Overload

(RADAR-Canada Trial)

Recruiting in Palo Alto (17 mi)

Overseen by John C Marshall, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Unity Health Toronto

No Placebo Group

Prior Safety Data

Trial Summary

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).

Research Team

John C Marshall, MD

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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 am 18 years old or older.

I was in the ICU for 5 days or less.

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.

Treatment Details

Interventions

• Furosemide (Diuretic)
• Metolazone (Diuretic)

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.

Participant Groups

Group I: Active deresuscitation Experimental Treatment 2 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 care Active Control 1 Intervention

Care at the discretion of the attending team.

Furosemide is already approved in Canada, Japan, China for the following indications:

Approved in Canada as Lasix for:

• Edema associated with congestive heart failure
• Liver cirrhosis
• Renal disease
• Nephrotic syndrome
• Hypertension

Approved in Japan as Lasix for:

• Edema associated with congestive heart failure
• Liver cirrhosis
• Renal disease
• Nephrotic syndrome

Approved in China as Lasix for:

• Edema associated with congestive heart failure
• Liver cirrhosis
• Renal disease
• Nephrotic syndrome
• Hypertension

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Dr. Sharon Straus

Unity Health Toronto

Chief Medical Officer

MD and MSc in Clinical Epidemiology, University of Toronto

Altaf Stationwala

Unity Health Toronto

Chief Executive Officer

Bachelor's degree in Health Administration, University of Ottawa

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa