NCT07447791

Brief Summary

Acute kidney injury is a potentially life threatening condition which affects 1 in 2 patients in the Intensive Care Unit (ICU). Patients often need dialysis treatment, also called renal replacement therapy. Renal replacement therapy is a treatment that removes toxins and excess fluid from the blood stream. It consists of having a small plastic catheter in a vein in the neck or in the groin through which blood flows through a dialysis machine and is cleansed and excess water is removed. The cleansed blood is then returned to the patient via the same catheter. One of the major areas of uncertainty for doctors in the ICU is "What is the right intensity of renal replacement therapy for patients with acute kidney injury?" A higher intensity indeed removes more toxins but also removes other substances in the blood, including vitamins, nutrients and important medications. The current usual dose is around 25 ml/kg/hr but clinical practice in the UK is very variable and some patients routinely receive higher doses and some get lower doses. Data from large databases worldwide have suggested that a lower dose is safe and effective and may potentially allow the kidneys to recover faster but confirmation is lacking. In this study, the investigators investigate whether renal replacement therapy at a lower intensity is as effective and safe as currently used doses. Participants will be randomised to receiving renal replacement therapy at usual or lower intensity. There will be no change to any other aspects of treatment. The results will inform the investigators whether the study protocol is feasible and how best to design a future larger research study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Feb 2025Mar 2027

Study Start

First participant enrolled

February 15, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Acute Kidney Injury (Nontraumatic)Dialysis; Complications

Keywords

renal replacement therapydoseacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • total delivered effluent rate

    difference in the total delivered effluent rate per patient

    7 days

Secondary Outcomes (1)

  • Feasibility endpoints

    12 months

Other Outcomes (1)

  • adverse events

    14 days

Study Arms (2)

Low dose RRT

ACTIVE COMPARATOR

dose of CRRT 10-15ml/kg/hr

Procedure: low intensity of CRRT

standard dose RRT

ACTIVE COMPARATOR

usual intensity CRRT at dose determined by clinical team

Procedure: usual intensity of CRRT

Interventions

low intensity of CRRTPROCEDURE

usual intensity CRRT

Low dose RRT
usual intensity of CRRTPROCEDURE

usual intensity

standard dose RRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years
  • patient weight ≥ 55 kg
  • plan to start CRRT or within 24 hours of having started CRRT for AKI
  • expected to survive and receive CRRT for a duration of ≥ 48 hours

You may not qualify if:

  • indication for sustained higher dose-intensity CRRT
  • end-stage kidney disease receiving maintenance dialysis
  • previous receipt of RRT for AKI during the current hospitalization
  • inability to comply with the requirements of the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' Hospital

London, Greater London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gillian Radcliffe

    Guy's & St. Thomas Hospital

    STUDY CHAIR

Central Study Contacts

Marlies Ostermann, PhD

CONTACT

+442071883036m.ostermann@nhs.net

Gillian Radcliffe

CONTACT

00442071883036gill.radcliffe@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: non-blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 3, 2026

Study Start

February 15, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)