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Fluid Management

Protocol-based Fluid Management for Critical Illness (Probe-Fluid Trial)

N/A
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to the ICU
Age ≥ 18 years
Must not have
Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids during the next 48 hours
Severe burn injury (>10% of body surface area)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization through day 90
Awards & highlights

Summary

This trial tests a method to manage fluid levels in critically ill patients with severe kidney issues. The goal is to prevent and treat fluid buildup by removing excess fluid, potentially improving patient outcomes.

Who is the study for?
This trial is for adults over 18 in the ICU with acute kidney injury (AKI) who meet specific criteria related to changes in serum creatinine or urine output. They must be starting kidney replacement therapy soon or have started it within the last 48 hours. People can't join if they're not expected to receive full support, might leave ICU soon, have severe burns, extreme sodium levels, ongoing fluid loss, or if their care team thinks the trial isn't right for them.
What is being tested?
The study tests a protocol-based fluid management strategy against usual care in critically ill patients on kidney replacement therapy. The goal is to manage fluids more actively to prevent and treat fluid buildup by aiming for neutral or negative daily fluid balance.
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from imbalanced fluid levels such as dehydration or overhydration which could affect blood pressure, heart function, and electrolyte balance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently in the Intensive Care Unit.
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I am 18 years old or older.
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I am starting kidney replacement therapy soon or have started it within the last 2 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need ongoing IV fluids for the next 2 days due to fluid loss.
Select...
I have severe burns covering more than 10% of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within +/- 7 days of the 90-day time point following randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within +/- 7 days of the 90-day time point 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
Cumulative fluid balance
Secondary study objectives
Clinical: Death
Clinical: Hospital-free days
Clinical: ICU-free days
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Protocolized fluid removalExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Kidney Injury (AKI) include fluid resuscitation, diuretics, and renal replacement therapy (RRT). Fluid resuscitation aims to restore adequate blood flow to the kidneys by administering intravenous fluids, which helps to prevent further kidney damage. Diuretics are used to increase urine output and reduce fluid overload, which can alleviate pressure on the kidneys. Renal replacement therapy, such as dialysis, removes waste products and excess fluids from the blood when the kidneys are unable to do so. Regulation of fluid balance is crucial in AKI management because both fluid overload and dehydration can exacerbate kidney injury. Maintaining a neutral or negative fluid balance, as studied in fluid management protocols, helps to optimize kidney function and improve patient outcomes.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
372 Previous Clinical Trials
130,881 Total Patients Enrolled
4 Trials studying Acute Kidney Injury
325 Patients Enrolled for Acute Kidney Injury
William Beaubien-Souligny, MD PhDStudy ChairCHUM
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
75 Patients Enrolled for Acute Kidney Injury
Ron Wald, MDCM MPHStudy ChairUnity Health Toronto
2 Previous Clinical Trials
3,119 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
3,119 Patients Enrolled for Acute Kidney Injury

Media Library

Protocol-based fluid management (Fluid Management) Clinical Trial Eligibility Overview. Trial Name: NCT05473143 — N/A
Acute Kidney Injury Research Study Groups: Protocolized fluid removal, Usual care
Acute Kidney Injury Clinical Trial 2023: Protocol-based fluid management Highlights & Side Effects. Trial Name: NCT05473143 — N/A
Protocol-based fluid management (Fluid Management) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473143 — N/A
~62 spots leftby Sep 2025
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