ClinicalTrials.gg
Status unknownNCT06471777PROBE Fluid UKUpdated Jun 26, 2024

Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on KRT Trial in UK

An interventional study of Fluid removal in Acute Renal Failure on Dialysis (Disorder), sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acute Renal Failure on Dialysis (Disorder)

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Keywords

  • acute kidney injury
  • dialysis
  • fluid removal
03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult patients aged ≥18 years
  2. Admitted to the intensive care unit
  3. Acute kidney injury defined by the KDIGO criteria
  4. Planned initiation of KRT within 12 hours or the receipt of KRT for AKI for ≤48 hours

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Probable discharge from the ICU within 48 hours according to treating clinician
  3. Severe burn injury (>10% of body surface area)
  4. Severe abnormality in serum sodium (>155 or \<120 mmol/L)
  5. Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids during the next 48 hours
  6. The clinical care team believes that the proposed intervention is inappropriate
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Protocol-based fluid removal

    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.

    Procedure: Fluid removal

  • No intervention
    Usual care

    Fluid removal during KRT will be determined by the attending clinical team.

Interventions

  • ProcedureFluid removal

    Fluid removal during kidney replacement therapy

06

What researchers measure

Primary outcomes

  1. fluid balance

    cumulative fluid balance

    Time frame: day 5 after randomization

Secondary outcomes

  1. enrolment

    Proportion of eligible patients who were enrol in the trial

    Time frame: 20 months

  2. mortality

    all-cause mortality

    Time frame: 90 days after randomization

  3. ICU stay

    Number of ICU free days

    Time frame: 90 days after randomization

  4. vasoactive therapy

    Number of vasoactive therapy-free days

    Time frame: 28 days after randomization

  5. mechanical ventilation

    Number of mechanical ventilation-free days

    Time frame: 28 days after randomization

  6. KRT duration

    hours of KRT support

    Time frame: 5 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06471777
Collaborators
Université de Montréal
Responsible party
Sponsor
First posted
Jun 24, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jun 26, 2024

Study contacts

Marlies Ostermann (work), PhD
Contact
marlies.ostermann@gstt.nhs.uk
02071887188 ext. 83036
Gillian Radcliffe
Contact
Gillian.Radcliffe@gstt.nhs.uk
02071887188 ext. 83036

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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