Acute Renal Failure on Dialysis (Disorder)PROBE Fluid UKNCT06471777
Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on KRT Trial in UK
A study testing Fluid removal in people with Acute Renal Failure on Dialysis (Disorder), run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure on Dialysis (Disorder)
- What is being tested?
- Fluid removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients aged ≥18 years
- Admitted to the intensive care unit
- Acute kidney injury defined by the KDIGO criteria
- Planned initiation of KRT within 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 clinician
- Probable discharge from the ICU within 48 hours according to treating clinician
- 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 during the next 48 hours
- The clinical care team believes that the proposed intervention is inappropriate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Proactive Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on Kidney Replacement Therapy Trial in UK
The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.
Read the detailed description
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, often leading to fluid overload. Congestion resulting from fluid accumulation is believed to contribute to organ failure. Removal of excess fluid is a central component of dialysis treatment, also known as kidney replacement therapy (KRT). However, there remain important knowledge gaps in our ability to remove excess fluid effectively and safely. If fluid is removed too slowly, fluid overload and its complications persist for longer. If fluid is removed too fast during KRT, patient's blood pressure may drop (ie hemodynamic instability may occur) which may precipitate complications.
The optimal fluid management strategy is currently unknown.
The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later. Secondary outcomes will include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
- Being tested
- Fluid removal
- Keywords
- acute kidney injury, dialysis, fluid removal
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid removalProcedure or surgery
Fluid removal during kidney replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Protocol-based fluid removal | Experimental | The intervention will consist of 3 components:
The first component of this prescription will be to define the 24h-fluid balance target. The second component is to specify a prescription for fluid removal. The third component is to prompt a daily re-evaluation of fluid intake and fluid balance by the attending care team. Receives: Procedure: Fluid removal |
| Usual care | No intervention | Fluid removal during KRT will be determined by the attending clinical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid balance
cumulative fluid balance
Measured: day 5 after randomization
Secondary outcomes (6)
enrolment
Proportion of eligible patients who were enrol in the trial
Measured: 20 months
mortality
all-cause mortality
Measured: 90 days after randomization
ICU stay
Number of ICU free days
Measured: 90 days after randomization
vasoactive therapy
Number of vasoactive therapy-free days
Measured: 28 days after randomization
mechanical ventilation
Number of mechanical ventilation-free days
Measured: 28 days after randomization
KRT duration
hours of KRT support
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal Failure on Dialysis (Disorder)Studies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471777
- Sponsor's protocol ID
- GSTT V1
- Acronym
- PROBE Fluid UK
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on Kidney Replacement Therapy Trial in UK
- ClinicalTrials.gov ID
- NCT06471777
- Acronym / sponsor ID
- PROBE Fluid UK / GSTT V1
- Keywords
- acute kidney injury, dialysis, fluid removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 Jun 2024 (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.
The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.
Detailed description
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, often leading to fluid overload. Congestion resulting from fluid accumulation is believed to contribute to organ failure. Removal of excess fluid is a central component of dialysis treatment, also known as kidney replacement therapy (KRT). However, there remain important knowledge gaps in our ability to remove excess fluid effectively and safely. If fluid is removed too slowly, fluid overload and its complications persist for longer. If fluid is removed too fast during KRT, patient's blood pressure may drop (ie hemodynamic instability may occur) which may precipitate complications.
The optimal fluid management strategy is currently unknown.
The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later. Secondary outcomes will 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 |
|---|---|---|
| Protocol-based fluid removal | Experimental | Procedure: Fluid removalThe intervention will consist of 3 components: The first component of this prescription will be to define the 24h-fluid balance target. The second component is to specify a prescription for fluid removal. The third component is to prompt a daily re-evaluation of fluid intake and fluid balance by the attending care team. |
| Usual care | No intervention | –Fluid removal during KRT will be determined by the attending clinical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged ≥18 years
- Admitted to the intensive care unit
- Acute kidney injury defined by the KDIGO criteria
- Planned initiation of KRT within 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 clinician
- Probable discharge from the ICU within 48 hours according to treating clinician
- 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 during 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 |
|---|---|---|
| Fluid removalFluid removal during kidney replacement therapy | Procedure or surgery | Protocol-based fluid removal |
Primary outcome
fluid balance
Time frame: day 5 after randomization
cumulative fluid balance
6 secondary outcomes
enrolment
Time frame: 20 months
mortality
Time frame: 90 days after randomization
ICU stay
Time frame: 90 days after randomization
vasoactive therapy
Time frame: 28 days after randomization
mechanical ventilation
Time frame: 28 days after randomization
KRT duration
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid removal in people with Acute Renal Failure on Dialysis (Disorder), run by Guy's and St Thomas' NHS Foundation Trust.
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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlies Ostermann (work), PhD (02071887188 ext. 83036, marlies.ostermann@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid balance (time frame: day 5 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2024.