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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Renal Failure on Dialysis (Disorder)
• Intervention / Treatment: Procedure: Fluid removal

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlies Ostermann (work), PhD; Phone Number: 83036 02071887188; Email: marlies.ostermann@gstt.nhs.uk
• Study Contact Backup: Name: Gillian Radcliffe; Phone Number: 83036 02071887188; Email: Gillian.Radcliffe@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Fluid removal during kidney replacement therapy
No Intervention: Usual care; Fluid removal during KRT will be determined by the attending clinical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fluid balance	cumulative fluid balance	day 5 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	all-cause mortality	90 days after randomization
KRT duration	hours of KRT support	5 days
enrolment	Proportion of eligible patients who were enrol in the trial	20 months
ICU stay	Number of ICU free days	90 days after randomization
vasoactive therapy	Number of vasoactive therapy-free days	28 days after randomization
mechanical ventilation	Number of mechanical ventilation-free days	28 days after randomization

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Université de Montréal

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: dialysis; acute kidney injury; fluid removal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: GSTT V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No