Acute Kidney Injury Clinical Trial
— BACKDOOROfficial title:
A Randomized Controlled Trial of Tunneled Dialysis Catheters Versus Non-tunneled Dialysis Catheters for Renal Replacement Therapy in the ICU
The investigators propose a randomized controlled trial to examine whether tunneled dialysis catheters should be first-line for acute kidney injury requiring renal replacement therapy (AKI-RRT) in the critical care setting, barring any clinical contraindications, compared to non-tunneled access. This randomized controlled trial will include patients admitted to an intensive care unit (ICU) at Brigham and Women's Hospital (BWH). The investigators will randomize all eligible consented incident patients with AKI requiring renal replacement therapy either to tunneled dialysis catheter or non-tunneled dialysis catheter placement. The inclusion criteria encompasses all adult patients in the BWH ICUs with an incident AKI requiring renal replacement therapy. The investigators' hypothesis is that the rate of overall complications is lower with tunneled dialysis catheters compared to non-tunneled catheters.
Status | Not yet recruiting |
Enrollment | 102 |
Est. completion date | September 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: All adult patients in the BWH ICUs with an incident AKI requiring renal replacement therapy Exclusion Criteria: 1. Clinical instability requiring bedside catheter placement 2. INR >2.0 or other significant coagulopathy 3. Pending blood cultures within 48 hours or active bacteremia 4. Urgency of line placement warranting placement within 6 hours. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Brigham and Women's Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of complications | Composite outcome including rate of infection and thrombosis. The incidence of both of these adverse events will be added together to give a composite rate of complications. | Up to 60 days | |
Secondary | Dialysis venous access pressure | Median venous access pressure | Up to 60 days | |
Secondary | Dialysis arterial access pressure | Median arterial access pressure | Up to 60 days | |
Secondary | Dialysis blood flow rate | Median blood flow rate | Up to 60 days | |
Secondary | Feasibility of tunneled catheter placement for AKI | Time to catheter placement | Up to 60 days | |
Secondary | Cost of dialysis access placement for AKI | Cost of dialysis catheter placement | Up to 60 days |
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