Guy's & St Thomas' Hospital
London, Greater London, SE1 7EH, United Kingdom
Location status: Recruiting
NCT Number: NCT07447791
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
London, Greater London, SE1 7EH, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
usual intensity CRRT
usual intensity
Time frame: 7 days
difference in the total delivered effluent rate per patient
Time frame: 12 months
number of enrolled patients
Time frame: 14 days
number of trial related adverse events per patient
Contact information is provided by the study sponsor or research team.
Gillian Radcliffe
CONTACT
Marlies Ostermann, PhD
CONTACT
Guy's and St Thomas' NHS Foundation Trust
Other
WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity Continuous Renal Replacement Therapy in Critically Ill Patients: a Randomized Trial
Acronym: WISDOM UK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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