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

NCT ID: NCT06471777

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-08-01

Brief 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.

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.

Conditions

Acute Renal Failure on Dialysis (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluid removal

Intervention Type: PROCEDURE

Fluid removal during kidney replacement therapy

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluid removal

Fluid removal during kidney replacement therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Marlies Ostermann (work), PhD

Role: CONTACT

marlies.ostermann@gstt.nhs.uk

02071887188 ext. 83036

Gillian Radcliffe

Role: CONTACT

Gillian.Radcliffe@gstt.nhs.uk

02071887188 ext. 83036

Other Identifiers

GSTT V1

Identifier Type: -

Identifier Source: org_study_id