Acute Kidney InjuryProbe-FluidNCT05473143
Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy
A study testing Protocol-based fluid management in people with Acute Kidney Injury and Kidney Replacement, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Kidney Replacement, Critical Illness
- What is being tested?
- Protocol-based fluid management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admitted to the ICU
- AKI during current hospitalization defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(1) as any of the following: Increase in serum creatinine by 27 µmol/L or more within any 48-hour window, or an increase in serum creatinine to 1.5 times baseline or more within the last 7 days, or a urine output less than 0.5 mL/kg/h for 6 hours.
- Planned initiation of KRT within the following 12 hours or the receipt of KRT for AKI for ≤48 hours
Who cannot join
- Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating physician
- Probable discharge from the ICU within the next 48 hours according to treating physician
- Severe burn injury (>10% of body surface area)
- Severe abnormality in serum sodium (>155 or <120 mmol/L)
- Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids uring the next 48 hours
- The clinical care team believes that the proposed intervention is inappropriate.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X0A9
About this study
A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.
Read the detailed description
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, thus making fluid removal a central component of the renal replacement therapy (KRT) prescription. Whereas the achievement and maintenance of euvolemia are critical objectives in the care of critically ill patients with severe AKI, there remain important knowledge gaps in our ability to effectively and safely deliver ultrafiltration. Multisystemic congestion resulting from fluid accumulation is believed to mediate adverse outcomes in this population and the timely use of mechanical fluid removal may improve prognosis. However, fluid removal may be associated with hemodynamic instability during KRT which may precipitate complications. The optimal fluid management strategy is currently unknown.
The study is a pilot randomized clinical trial comparing a protocol-based fluid management strategy with usual care in critically ill patients receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. The protocol was designed to provide a standardized framework to prescribe fluid removal while allowing the attending care team to modify treatment targets according to their clinical evaluation.
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from randomization to 5 days. Feasibility will be documented including the ability to enroll the target population, protocol adherence, and the capacity to achieve follow-up through 90 days. Secondary outcomes will also include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
- Conditions
- Acute Kidney Injury, Kidney Replacement, Critical Illness
- Being tested
- Protocol-based fluid management, Usual care
- Keywords
- Fluid balance management, Ultrafiltration
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-based fluid managementOther
Fluid removal will be prescribed using a standardized template updated at least once per working day, before noon of each day, by the attending care team. This protocolized prescription will contain three components. Fluid removal will be prescribed using a standardized template updated at least once per working day, before noon of each day, by the attending care team. This protocolized prescription will contain three components.
The first component of this prescription will be to define the 24h-fluid balance target either aiming for a negative fluid balance of 2 to 3% body weight (1.4-2.1 liters in a 70 Kg participant) (Option 1) or by aiming to avoid fluid accumulation by targeting a neutral fluid balance within 0.5% of body weight variation (-350 to +350 mL in a 70 Kg participant) (Option 2).
The second component is to pre-specify a prescription for fluid removal using KRT.
The third component is to prompt a daily re-evaluation of fluid intake by the attending care team.
Usual careOther
The net fluid removal and the rate of net fluid removal will not be protocolized and will be prescribed and adjusted according to the attending care team without any specific guidance. The use of the documents provided for the intervention group will not be permitted in the control arm.
| Study group | Role | What they receive |
|---|---|---|
| Protocolized fluid removal | Experimental | Not described Receives: Other: Protocol-based fluid management |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative fluid balance
The difference between quantifiable fluid intake and output
Measured: From randomization to the end of day 5
Secondary outcomes (18)
Feasibility: Ability to successfully enroll
Target >30% of fully eligible patients
Measured: During screening and enrolment
Feasibility: Protocol adherence
defined as >80% of participants adhering to the allocated treatment for 5 days after enrolment
Measured: From randomization to the end of day 5
Feasibility: Ability to achieve follow-up
Ability to achieve > 95% follow-up regarding all clinical outcomes
Measured: From randomization through day 90.
Clinical: Death
Death from any cause
Measured: From randomization through day 90.
Clinical: Vasoactive therapy-free days
A vasoactive-free day will be defined as ≥ 2 hours of receipt of any vasoactive therapy provided by continuous infusion within a 24 hour period. Vasoactive therapy include norepinephrine, vasopressin, phenylephrine, epinephrine, dopamine >5mcg/kg/min, and angiotensin II.
Measured: From randomization through day 28.
Clinical: Mechanical ventilation-free days
A ventilator-free day will be defined as the receipt of ≥ 2 hours of mechanical ventilation within a 24-hour period.
Measured: From randomization through day 28.
Clinical: KRT-free days
An KRT-free day will be defined receiving any KRT modality for ≥ 2 hours within a 24 hours period.
Measured: From randomization through day 28.
Clinical: ICU-free days
An ICU-free day will be defined as admission to an ICU for ≥ 2 hours within a 24 hours period.
Measured: From randomization through day 90
Clinical: Hospital-free days
Hospital-free days will be defined as a 24-hour period completely free of an inpatient hospitalization.
Measured: From randomization through day 90
Dependence on KRT
KRT dependence will be defined by the receipt of any form of KRT
Measured: within +/- 7 days of the 90-day time point following randomization.
Resource use: cumulative time of continuous KRT
Total cumulative duration in hours
Measured: From randomization to the end of day 5
Resource use: cumulative time of intermittent KRT
Total cumulative duration in hours
Measured: From randomization to the end of day 5
Safety: Maximal vasopressor requirements
Maximal vasopressor requirements as per the vasoactive-inotropic score recorded during each 24-hour period.
Measured: From randomization to the end of day 5
Safety: Severity of illness
Total sequential organ failure assessment (SOFA) score recorded during each 24-hour period.
Measured: From randomization to the end of day 5
Process measures: Target fluid balance as prescribed in the initial fluid balance prescription for the day
Measured: From randomization to the end of day 5
Process measures: Proportion of time in which a neutral fluid balance target is selected by the clinical care team
Measured: From randomization to the end of day 5
Process measures: Clinical elements used to assess fluid accumulation
Measured: From randomization to the end of day 5
Process measures: The difference between the original target and the fluid balance achieved at the end of each 24-hour period
Measured: From randomization to the end of day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start3 Apr 2023
- Primary completion1 Jan 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Beaubien-Souligny, MD PhD, Study chair, CHUMRon Wald, MDCM MPH, Study chair, Unity Health TorontoSean Bagshaw, MD MSc, Study chair, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473143
- Sponsor's protocol ID
- MP-02-2023-10829
- Acronym
- Probe-Fluid
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen A, Bouchard J, Neyra JA, Lamontagne F, Cote JM, Clark EG, da Costa BR, Gallagher M, Adhikari NKJ, Silver SA, Suri RS, Ostermann M, Neto AS, Bellomo R, Bagshaw SM, Wald R, Beaubien-Souligny W. Proactive Prescription-Based Fluid Management Versus Usual Care in Critically Ill Patients on Kidney Replacement Therapy (Probe-Fluid): A Pilot Clinical Trial Protocol. Can J Kidney Health Dis. 2025 Dec 9;12:20543581251391877. doi: 10.1177/20543581251391877. eCollection 2025.
PubMed 41393271
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy
- ClinicalTrials.gov ID
- NCT05473143
- Acronym / sponsor ID
- Probe-Fluid / MP-02-2023-10829
- Conditions
- Acute Kidney Injury, Kidney Replacement, Critical Illness
- Keywords
- Fluid balance management, Ultrafiltration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.
Detailed description
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, thus making fluid removal a central component of the renal replacement therapy (KRT) prescription. Whereas the achievement and maintenance of euvolemia are critical objectives in the care of critically ill patients with severe AKI, there remain important knowledge gaps in our ability to effectively and safely deliver ultrafiltration. Multisystemic congestion resulting from fluid accumulation is believed to mediate adverse outcomes in this population and the timely use of mechanical fluid removal may improve prognosis. However, fluid removal may be associated with hemodynamic instability during KRT which may precipitate complications. The optimal fluid management strategy is currently unknown.
The study is a pilot randomized clinical trial comparing a protocol-based fluid management strategy with usual care in critically ill patients receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. The protocol was designed to provide a standardized framework to prescribe fluid removal while allowing the attending care team to modify treatment targets according to their clinical evaluation.
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from randomization to 5 days. Feasibility will be documented including the ability to enroll the target population, protocol adherence, and the capacity to achieve follow-up through 90 days. Secondary outcomes will also include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocolized fluid removal | Experimental | Other: Protocol-based fluid management |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Admitted to the ICU
- AKI during current hospitalization defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(1) as any of the following: Increase in serum creatinine by 27 µmol/L or more within any 48-hour window, or an increase in serum creatinine to 1.5 times baseline or more within the last 7 days, or a urine output less than 0.5 mL/kg/h for 6 hours.
- Planned initiation of KRT within the following 12 hours or the receipt of KRT for AKI for ≤48 hours
Key exclusion criteria (6 listed)
- Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating physician
- Probable discharge from the ICU within the next 48 hours according to treating physician
- Severe burn injury (>10% of body surface area)
- Severe abnormality in serum sodium (>155 or <120 mmol/L)
- Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids uring the next 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol-based fluid managementFluid removal will be prescribed using a standardized template updated at least once per working day, before noon of each day, by the attending care team. This protocolized prescription will contain three components. Fluid removal will be prescribed using a standardized template updated at least once per working day, before noon of each day, by the attending care team. This protocolized prescription will contain three components. The first component of this prescription will be to define the 24h-fluid balance target either aiming for a negative fluid balance of 2 to 3% body weight (1.4-2.1 liters in a 70 Kg participant) (Option 1) or by aiming to avoid fluid accumulation by targeting a neutral fluid balance within 0.5% of body weight variation (-350 to +350 mL in a 70 Kg participant) (Option 2). The second component is to pre-specify a prescription for fluid removal using KRT. The third component is to prompt a daily re-evaluation of fluid intake by the attending care team. | Other | Protocolized fluid removal |
| Usual careThe net fluid removal and the rate of net fluid removal will not be protocolized and will be prescribed and adjusted according to the attending care team without any specific guidance. The use of the documents provided for the intervention group will not be permitted in the control arm. | Other | Usual care |
Primary outcome
Cumulative fluid balance
Time frame: From randomization to the end of day 5
The difference between quantifiable fluid intake and output
18 secondary outcomes
Feasibility: Ability to successfully enroll
Time frame: During screening and enrolment
Feasibility: Protocol adherence
Time frame: From randomization to the end of day 5
Feasibility: Ability to achieve follow-up
Time frame: From randomization through day 90.
Clinical: Death
Time frame: From randomization through day 90.
Clinical: Vasoactive therapy-free days
Time frame: From randomization through day 28.
Clinical: Mechanical ventilation-free days
Time frame: From randomization through day 28.
Clinical: KRT-free days
Time frame: From randomization through day 28.
Clinical: ICU-free days
Time frame: From randomization through day 90
Clinical: Hospital-free days
Time frame: From randomization through day 90
Dependence on KRT
Time frame: within +/- 7 days of the 90-day time point following randomization.
Resource use: cumulative time of continuous KRT
Time frame: From randomization to the end of day 5
Resource use: cumulative time of intermittent KRT
Time frame: From randomization to the end of day 5
Safety: Maximal vasopressor requirements
Time frame: From randomization to the end of day 5
Safety: Severity of illness
Time frame: From randomization to the end of day 5
Process measures: Target fluid balance as prescribed in the initial fluid balance prescription for the day
Time frame: From randomization to the end of day 5
Process measures: Proportion of time in which a neutral fluid balance target is selected by the clinical care team
Time frame: From randomization to the end of day 5
Process measures: Clinical elements used to assess fluid accumulation
Time frame: From randomization to the end of day 5
Process measures: The difference between the original target and the fluid balance achieved at the end of each 24-hour period
Time frame: From randomization to the end of day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 41393271Shen A, Bouchard J, Neyra JA, Lamontagne F, Cote JM, Clark EG, da Costa BR, Gallagher M, Adhikari NKJ, Silver SA, Suri RS, Ostermann M, Neto AS, Bellomo R, Bagshaw SM, Wald R, Beaubien-Souligny W. Proactive Prescription-Based Fluid Management Versus Usual Care in Critically Ill Patients on Kidney Replacement Therapy (Probe-Fluid): A Pilot Clinical Trial Protocol. Can J Kidney Health Dis. 2025 Dec 9;12:20543581251391877. doi: 10.1177/20543581251391877. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Beaubien-Souligny, MD PhD study chair
CHUM
Ron Wald, MDCM MPH study chair
Unity Health Toronto
Sean Bagshaw, MD MSc study chair
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol-based fluid management in people with Acute Kidney Injury and Kidney Replacement, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fluid balance (time frame: From randomization to the end of day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.