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Tunneled Dialysis Catheters Versus Non-tunneled Dialysis Catheters as First-line for Renal Replacement Therapy in the ICU (BACKDOOR)

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ClinicalTrials.gov Identifier: NCT03496935
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yvelynne Kelly M.D. MSc., Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Device: Tunneled versus non-tunneled dialysis catheter insertion Not Applicable

Detailed Description:

Acute kidney injury (AKI) is defined by an abrupt decrease in kidney function resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. AKI is common, harmful and potentially treatable.

Despite decades of research, renal replacement therapy (RRT) in the form of dialysis remains the primary therapy to treat AKI and its complications. Due to convenience of scheduling and distribution of expertise, non-tunneled dialysis catheters have generally been the first-line source of vascular access for patients requiring acute dialysis for AKI in the ICU setting. However, there is evidence that tunneled dialysis catheters are associated with improved outcomes compared to non-tunneled dialysis catheters.

The investigators for this proposed trial performed an observational study at Brigham and Women's Hospital in 2016 comparing outcomes from temporary dialysis catheter versus tunneled dialysis catheter use for renal replacement therapy in the ICU.12 They found that there was a significant increase in median venous and arterial access pressure between temporary dialysis catheters and tunneled dialysis catheters for patients on CVVH with an increased rate ratio of interruptions and decreased blood flow rates for temporary dialysis catheters compared to tunneled dialysis catheters

The investigators now propose a prospective randomized controlled trial to examine whether tunneled dialysis catheters should be first-line for AKI-RRT in the critical care setting, barring any clinical contraindications, compared to non-tunneled access. This RCT will include patients admitted to an ICU at Brigham and Women's Hospital. 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. Exclusion criteria will include 1) clinical instability requiring bedside catheter placement; 2) international normalized ratio (INR) >2.0 or other significant coagulopathy; 3) pending blood cultures within 48 hours or active bacteremia; or 4) urgency of line placement warranting placement within 6 hours. To avoid bias introduced by operator performance, the same group of interventional nephrologists will be utilized to place the catheters in both arms of the trial. The investigators' hypothesis is that the rate of overall complications is lower with tunneled dialysis catheters compared to non-tunneled catheters. Other secondary outcomes of interest include dialysis delivery parameters including access pressures and blood flow rates. The investigators also plan to assessing the feasibility of tunneled dialysis catheter placement for AKI, by capturing data on time to placement, resource utilization and cost. The proposal challenges a common clinical practice; placement of non-tunneled catheters for RRT initiation, which is not evidence-based, to determine if tunneled catheters can improve outcomes for patients compared to usual care.

The investigators will identify all patients with AKI requiring vascular access by reviewing inpatient renal consult patient lists and electronic orders for intermittent hemodialysis (IHD) or continuous renal replacement therapy (CRRT) initiation. Data will be prospectively collected on demographics, comorbidities, laboratory data, and microbiology results on a daily basis. Data will also be abstracted from procedure notes to identify procedural complications. Similarly, CVVH and IHD data (blood flow rates, venous and arterial pressures, total time of RRT per session, and number of interruptions during RRT) will be gathered prospectively on a daily basis from RRT flowsheets and RRT nursing notes. Patients will be followed throughout the entirety of the hospitalization until hospital discharge or death.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Tunneled Dialysis Catheters Versus Non-tunneled Dialysis Catheters for Renal Replacement Therapy in the ICU
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Tunneled dialysis catheter
In this arm, patients will be randomized to undergo tunneled dialysis catheter insertion.
Device: Tunneled versus non-tunneled dialysis catheter insertion
The study participants will be randomized either to tunneled or non-tunneled dialysis catheter insertion to commence renal replacement therapy for an acute kidney injury requiring either continuous or intermittent dialysis in the ICU.

Active Comparator: Non-tunneled dialysis catheter
In this arm, patients will be randomized to undergo non-tunneled dialysis catheter insertion.
Device: Tunneled versus non-tunneled dialysis catheter insertion
The study participants will be randomized either to tunneled or non-tunneled dialysis catheter insertion to commence renal replacement therapy for an acute kidney injury requiring either continuous or intermittent dialysis in the ICU.




Primary Outcome Measures :
  1. Rate of complications [ Time Frame: Up to 60 days ]
    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.


Secondary Outcome Measures :
  1. Dialysis venous access pressure [ Time Frame: Up to 60 days ]
    Median venous access pressure

  2. Dialysis arterial access pressure [ Time Frame: Up to 60 days ]
    Median arterial access pressure

  3. Dialysis blood flow rate [ Time Frame: Up to 60 days ]
    Median blood flow rate

  4. Feasibility of tunneled catheter placement for AKI [ Time Frame: Up to 60 days ]
    Time to catheter placement

  5. Cost of dialysis access placement for AKI [ Time Frame: Up to 60 days ]
    Cost of dialysis catheter placement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496935


Contacts
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Contact: Yvelynne P Kelly, M.D. MSc. 857-350-0573 ypkelly@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Mallika Mendu, M.D. MBA. Brigham and Women's Hospital

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Responsible Party: Yvelynne Kelly M.D. MSc., Nephrology Fellow, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03496935     History of Changes
Other Study ID Numbers: 2018P000711
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yvelynne Kelly M.D. MSc., Brigham and Women's Hospital:
Renal replacement therapy

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases