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Recruiting NCT07447791

WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity CRRT in Critically Ill Patients

No phase Interventional Acute Kidney Injury (Nontraumatic) Dialysis; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low intensity of CRRT, usual intensity of CRRT.
Who it may be relevant to
Registry conditions: Acute Kidney Injury (Nontraumatic), Dialysis; Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity Continuous Renal Replacement Therapy in Critically Ill Patients: a Randomized Trial

Overview

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.

Detailed description

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 investigators aim to recruit 20 patients in the UK. Fully anonymised results will be shared with researchers in Canada who are conducting the same study.

Interventions

  • Procedure low intensity of CRRT
    usual intensity CRRT
  • Procedure usual intensity of CRRT
    usual intensity

Primary outcome measures

  • total delivered effluent rate [Time frame: 7 days]
Secondary outcome measures (1)
  • Feasibility endpoints [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Guy's & St Thomas' Hospital — London

Identifiers

NCT: NCT07447791 · WISDOM UK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗