- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447791
WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity CRRT in Critically Ill Patients (WISDOM UK)
WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity Continuous Renal Replacement Therapy in Critically Ill Patients: a Randomized Trial
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marlies Ostermann, PhD
- Phone Number: +442071883036
- Email: m.ostermann@nhs.net
Study Contact Backup
- Name: Gillian Radcliffe
- Phone Number: 00442071883036
- Email: gill.radcliffe@nhs.net
Study Locations
-
-
Greater London
-
London, Greater London, United Kingdom, SE1 7EH
- Recruiting
- Guy's & St Thomas' Hospital
-
Contact:
- Marlies Ostermann
- Phone Number: 07742514213
- Email: Marlies.Ostermann@gstt.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Low dose RRT
dose of CRRT 10-15ml/kg/hr
|
usual intensity CRRT
|
|
Active Comparator: standard dose RRT
usual intensity CRRT at dose determined by clinical team
|
usual intensity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total delivered effluent rate
Time Frame: 7 days
|
difference in the total delivered effluent rate per patient
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility endpoints
Time Frame: 12 months
|
number of enrolled patients
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adverse events
Time Frame: 14 days
|
number of trial related adverse events per patient
|
14 days
|
Collaborators and Investigators
Investigators
- Study Chair: Gillian Radcliffe, Guy's & St. Thomas Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WISDOM UK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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