Dialysis Catheter Comparative Clinical Trial

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Tyco Healthcare Group

ClinicalTrials.gov Identifier:

NCT00526123

First received: September 5, 2007

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Results First Received: August 30, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	End Stage Renal Disease
Interventions:	Device: Symmetric Tip Catheter Device: Conventional Split-tip Catheter

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with ESRD requiring hemodialysis via a chronic hemodialysis catheter at least 3x weekly for a minimum of 6 weeks were recruited from the clinical study sites. Participating sites included hospitals and private medical clinics. Subjects were enrolled from September 2007 through January 2011

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients that met all of the eligibility criteria were enrolled and were randomized 1:1 to either the symmetric tip or split-tip catheter group. Enrolled subjects were further stratified via subject ID by new catheter insertion versus catheter exchange.

Reporting Groups

	Description
Symmetric Tip	symmetric tip hemodialysis catheter
Split-tip	split-tip hemodialysis catheter

Participant Flow: Overall Study

	Symmetric Tip	Split-tip
STARTED	303 ^[1]	296 ^[1]
COMPLETED	39	50
NOT COMPLETED	264	246

[1]	Intent-to-Treat population

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Symmetric Tip	symmetric tip hemodialysis catheter
Split-tip	split-tip hemodialysis catheter
Total	Total of all reporting groups

Baseline Measures

	Symmetric Tip	Split-tip	Total
Number of Participants [units: participants]	303	296	599
Age [units: participants]
<=18 years	0	1	1
Between 18 and 65 years	189	180	369
>=65 years	114	115	229
Age [units: years] Mean ± Standard Deviation	60.0 ± 14.49	58.9 ± 15.34	59.5 ± 14.92
Gender [units: participants]
Female	160	149	309
Male	143	147	290
Region of Enrollment [units: participants]
United States	303	296	599

Outcome Measures

Show All Outcome Measures

1. Primary:

First Catheter Induced Complication [ Time Frame: 30 days ]

Show Outcome Measure 1

2. Primary:

First Catheter Induced Complication [ Time Frame: 60 days ]

Show Outcome Measure 2

3. Primary:

First Catheter Induced Complication [ Time Frame: 245 days ]

Show Outcome Measure 3

4. Secondary:

Inadequate Flow Rates Requiring Surgical/Radiological Intervention [ Time Frame: 35 weeks ]

Show Outcome Measure 4

5. Secondary:

Average Number of Line Reversals Per Subject [ Time Frame: 35 Weeks ]

Show Outcome Measure 5

6. Secondary:

Frequency of Clinician Interventions for Catheter Malfunction and Infection [ Time Frame: 35 Weeks ]

Show Outcome Measure 6

7. Secondary:

Primary Failure Rate [ Time Frame: First dialysis session with study catheter ]

Show Outcome Measure 7

8. Secondary:

Reliability of the Catheter [ Time Frame: 35 Weeks ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: SPONSOR shall have the right to review and comment on such publication with respect to disclosure of SPONSOR Confidential Information prior to submission and review, and no such SPONSOR Confidential Information shall be disclosed therein without SPONSOR’s express written consent. Such review and comment will be provided within 30 calendar days from the date of receipt by the SPONSOR. Investigator shall delete any SPONSOR confidential information contained in such publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None

Results Point of Contact:

Name/Title: Dr. Klemens B. Meyer
Organization: Tufts Medical Center
phone: 617-636-9421
e-mail: kmeyer@tuftsmedicalcenter.org

No publications provided

Responsible Party:	Tyco Healthcare Group
ClinicalTrials.gov Identifier:	NCT00526123 History of Changes
Other Study ID Numbers:	341.26
Study First Received:	September 5, 2007
Results First Received:	August 30, 2012
Last Updated:	January 3, 2013
Health Authority:	United States: Institutional Review Board

To Top