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

NCT03496935 | Unknown DMC

• 1 other identifier: 2018P000711
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury

Keywords

Renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Dialysis venous access pressure

  Up to 60 days

• Dialysis arterial access pressure

  Up to 60 days

• Dialysis blood flow rate

  Up to 60 days

• Feasibility of tunneled catheter placement for AKI

  Up to 60 days

• Cost of dialysis access placement for AKI

  Up to 60 days

Study Arms (2)

Tunneled dialysis catheter

ACTIVE COMPARATOR

In this arm, patients will be randomized to undergo tunneled dialysis catheter insertion.

Device: Tunneled versus non-tunneled dialysis catheter insertion

Non-tunneled dialysis catheter

ACTIVE COMPARATOR

In this arm, patients will be randomized to undergo non-tunneled dialysis catheter insertion.

Device: Tunneled versus non-tunneled dialysis catheter insertion

Interventions

Tunneled versus non-tunneled dialysis catheter insertion DEVICE

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.

Non-tunneled dialysis catheter; Tunneled dialysis catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients in the BWH ICUs with an incident AKI requiring renal replacement therapy

You may not qualify if:

• Clinical instability requiring bedside catheter placement
• INR \>2.0 or other significant coagulopathy
• Pending blood cultures within 48 hours or active bacteremia
• Urgency of line placement warranting placement within 6 hours.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (1)

• Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

  PMID: 34519356 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mallika Mendu, M.D. MBA.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvelynne P Kelly, M.D. MSc.

CONTACT

857-350-0573; ypkelly@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Fellow

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 12, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share