Trial Outcomes & Findings for Dialysis Catheter Comparative Clinical Trial (NCT NCT00526123)

NCT ID: NCT00526123

Last Updated: 2013-01-07

Results Overview

% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 599 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2013-01-07

Participant Flow

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

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.

Participant milestones

Measure	Symmetric Tip symmetric tip hemodialysis catheter	Split-tip split-tip hemodialysis catheter
Overall Study STARTED	303	296
Overall Study COMPLETED	39	50
Overall Study NOT COMPLETED	264	246

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dialysis Catheter Comparative Clinical Trial

Baseline characteristics by cohort

Measure	Symmetric Tip n=303 Participants symmetric tip hemodialysis catheter	Split-tip n=296 Participants split-tip hemodialysis catheter	Total n=599 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	189 Participants n=5 Participants	180 Participants n=7 Participants	369 Participants n=5 Participants
Age, Categorical >=65 years	114 Participants n=5 Participants	115 Participants n=7 Participants	229 Participants n=5 Participants
Age Continuous	60.0 years STANDARD_DEVIATION 14.49 • n=5 Participants	58.9 years STANDARD_DEVIATION 15.34 • n=7 Participants	59.5 years STANDARD_DEVIATION 14.92 • n=5 Participants
Sex: Female, Male Female	160 Participants n=5 Participants	149 Participants n=7 Participants	309 Participants n=5 Participants
Sex: Female, Male Male	143 Participants n=5 Participants	147 Participants n=7 Participants	290 Participants n=5 Participants
Region of Enrollment United States	303 participants n=5 Participants	296 participants n=7 Participants	599 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.

% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
First Catheter Induced Complication	78 percentage of participants	77 percentage of participants

PRIMARY outcome

Timeframe: 60 days

Population: Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.

% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
First Catheter Induced Complication	66 percentage of participants	69 percentage of participants

PRIMARY outcome

Timeframe: 245 days

Population: Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.

% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
First Catheter Induced Complication	40 percentage of participants	48 percentage of participants

SECONDARY outcome

Timeframe: 35 weeks

Population: Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized.

Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.

Outcome measures

Measure	Symmetric Tip n=303 Participants symmetric tip hemodialysis catheter	Split-tip n=296 Participants split-tip hemodialysis catheter
Inadequate Flow Rates Requiring Surgical/Radiological Intervention	18 events	29 events

SECONDARY outcome

Timeframe: 35 Weeks

Population: Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.

Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
Average Number of Line Reversals Per Subject	6.5 events Standard Deviation 18.87	8.0 events Standard Deviation 21.01

SECONDARY outcome

Timeframe: 35 Weeks

Population: Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.

Average number of times clinician intervention was required for either catheter malfunction or infection

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
Frequency of Clinician Interventions for Catheter Malfunction and Infection	8.2 events Standard Deviation 12.22	10.0 events Standard Deviation 15.89

SECONDARY outcome

Timeframe: First dialysis session with study catheter

Population: Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had a study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.

The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
Primary Failure Rate	3.9 percentage of catheters	4.9 percentage of catheters

SECONDARY outcome

Timeframe: 35 Weeks

Population: Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had the study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.

Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.

Outcome measures

Measure	Symmetric Tip n=285 Participants symmetric tip hemodialysis catheter	Split-tip n=283 Participants split-tip hemodialysis catheter
Reliability of the Catheter	90.6 percentage of study visits Standard Deviation 20.10	86.9 percentage of study visits Standard Deviation 23.37

Adverse Events

Symmetric Tip

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Split-tip

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Symmetric Tip n=303 participants at risk symmetric tip hemodialysis catheter	Split-tip n=296 participants at risk split-tip hemodialysis catheter
Infections and infestations Bacteremia	0.33% 1/303 • Number of events 2 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Catheter Infection	0.66% 2/303 • Number of events 2 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Catheter-related bacteremia	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Catheter-related blood stream infection (CRBSI)	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Exit site infection	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Fever of unknown origin, bacteremia	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Gram negative bacteremia	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Infection	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Infection, permcath associated bacteremia	0.00% 0/303 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.34% 1/296 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Methicillin resistant staphylococcus aureus-sepsis (MRSA)	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Vascular disorders Pulmonary embolism (PE)	0.00% 0/303 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.34% 1/296 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Sepsis	0.00% 0/303 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.68% 2/296 • Number of events 3 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.
Infections and infestations Staph aureus bacteremia	0.33% 1/303 • Number of events 1 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.	0.00% 0/296 • Immediately following study catheter insertion any adverse effect that was determined by the Investigator to be possibly or probably related to the study catheter or study procedures was collected.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Klemens B. Meyer

Tufts Medical Center

Phone: 617-636-9421

Email: kmeyer@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER