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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose RRT | Active Comparator | dose of CRRT 10-15ml/kg/hr |
|
| standard dose RRT | Active Comparator | usual intensity CRRT at dose determined by clinical team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low intensity of CRRT | Procedure | usual intensity CRRT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| total delivered effluent rate | difference in the total delivered effluent rate per patient | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility endpoints | number of enrolled patients | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | number of trial related adverse events per patient | 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlies Ostermann, PhD | Contact | +442071883036 | m.ostermann@nhs.net | |
| Gillian Radcliffe | Contact | 00442071883036 | gill.radcliffe@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Gillian Radcliffe | Guy's & St. Thomas Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas' Hospital | Recruiting | London | Greater London | SE1 7EH | United Kingdom |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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non-blinded randomized controlled trial
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| usual intensity of CRRT |
| Procedure |
usual intensity |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |