Role of Active Deresuscitation After Resuscitation:

NCT06326112 | Not Yet Recruiting Phase 2

• 1 other identifier: 4588
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Fluid Overload; Critical Illness; Sepsis; ARDS; Trauma

Keywords

sepsis; acute respiratory distress syndrome; multiple trauma; critical illness

Outcome Measures

Primary Outcomes (3)

• Efficacy: Mean cumulative fluid balance

  Total fluid input (mL) - output (mL) in each group

  72 hours following randomization

• Compliance with deresuscitation protocol

  Daily fluid balance in mL \>10 liters, target \>2.0 liters/24 hours

  Each 24 hours over first week

• Acceptability of protocol

  Percentage of eligible patients who consent to randomization

  Day 1

Secondary Outcomes (3)

• All cause mortality

  90 days following randomization

• New onset organ dysfunction

  7 days following randomization

• Organ support-free days

  28 days following randomization

Other Outcomes (1)

• Inflammatory and renal biomarkers - change from baseline values

  3 days following randomization

Study Arms (2)

Active deresuscitation

EXPERIMENTAL

* 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

Drug: Furosemide Injection; Drug: Metolazone Tablets

Usual care

NO INTERVENTION

Care at the discretion of the attending team.

Interventions

Furosemide Injection DRUG

o.5 mg/kg bid or tid IV

Active deresuscitation

Metolazone Tablets DRUG

Diuretic as needed

Active deresuscitation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Mechanically ventilated for \> 48 hours
• Calculated volume accumulation \> 3 liters since ICU admission or pitting edema in at least two sites (arms, legs, or trunk)
• Admitted to ICU for ≤ five days
• Informed consent obtained from patient or alternate decision-maker

You may not qualify if:

• \. Lack of consent from patient or substitute decision maker or from responsible physician 2. Active bleeding (defined as \> 2 units transfused RBC in past 24 hours) 3. Hemodynamic instability (defined as use of vasopressors \>0.1 µg/kg/minute norepinephrine or equivalent, or increase in vasopressor dose over past 6 hours) 4. Currently receiving dialysis, or plans to initiate dialysis imminently 5. P/F ratio \< 75 6. Subarachnoid hemorrhage 7. Severe traumatic brain injury with admission GCS \<8 8. Diabetic ketoacidosis or hyperosmolar state 9. Acute cardiac failure or cardiogenic shock 10. Suspected or established diabetes insipidus 11. Allergy to furosemide 12. High probability of death within 24 hours

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Edema; Critical Illness; Sepsis; Wounds and Injuries; Respiratory Distress Syndrome; Multiple Trauma

Interventions

Furosemide; Metolazone

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Quinazolinones; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John C Marshall, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Romero, RN

CONTACT

416-864-6060; Laura.Romero@unityhealth.to

Michael Sklar, MD

CONTACT

416-864-6060; Michael.Sklar@unityhealth.to

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking of the health care team will not be feasible as they must administer the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Critical Care Medicine

Model Details: RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 22, 2024
• Study Start: May 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CA (1)