End Stage Renal Disease
Conditions
Keywords
Dialysis, Dialysis Catheter, Kidney Disease, Dialysis Clinic, Chronic Catheter, Catheter, Kidney
Brief summary
The purpose of this clinical trial is to compare the longevity of two dialysis catheters.
Detailed description
This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.
Interventions
DEVICESymmetric Tip Catheter
Dialysis catheter
DEVICEConventional Split-tip Catheter
Dialysis Catheter
Sponsors
Tyco Healthcare Group
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be 18 years of age or older. * Subject must meet labeled indication for hemodialysis. * Subject must have End Stage Renal Disease (ESRD). * Subject must have a patent right or left internal jugular vein. * Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks. * Subject must give written informed consent.
Exclusion criteria
* Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study. * Subjects with active infection at the time of study enrollment. * Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia. * Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding. * Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period. * Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason. * Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study. * Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Catheter Induced Complication | 30 days | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inadequate Flow Rates Requiring Surgical/Radiological Intervention | 35 weeks | Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'. |
| Average Number of Line Reversals Per Subject | 35 Weeks | Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments |
| Frequency of Clinician Interventions for Catheter Malfunction and Infection | 35 Weeks | Average number of times clinician intervention was required for either catheter malfunction or infection |
| Primary Failure Rate | First dialysis session with study catheter | 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. |
| Reliability of the Catheter | 35 Weeks | Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min. |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Symmetric Tip symmetric tip hemodialysis catheter | 303 |
| Split-tip split-tip hemodialysis catheter | 296 |
| Total | 599 |
Baseline characteristics
| Characteristic | Split-tip | Symmetric Tip | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 115 Participants | 114 Participants | 229 Participants |
| Age, Categorical Between 18 and 65 years | 180 Participants | 189 Participants | 369 Participants |
| Age Continuous | 58.9 years STANDARD_DEVIATION 15.34 | 60.0 years STANDARD_DEVIATION 14.49 | 59.5 years STANDARD_DEVIATION 14.92 |
| Region of Enrollment United States | 296 participants | 303 participants | 599 participants |
| Sex: Female, Male Female | 149 Participants | 160 Participants | 309 Participants |
| Sex: Female, Male Male | 147 Participants | 143 Participants | 290 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 303 | 0 / 296 |
| serious Total, serious adverse events | 11 / 303 | 4 / 296 |
Outcome results
Primary
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symmetric Tip | First Catheter Induced Complication | 78 percentage of participants |
| Split-tip | First Catheter Induced Complication | 77 percentage of participants |
Primary
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symmetric Tip | First Catheter Induced Complication | 66 percentage of participants |
| Split-tip | First Catheter Induced Complication | 69 percentage of participants |
Primary
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symmetric Tip | First Catheter Induced Complication | 40 percentage of participants |
| Split-tip | First Catheter Induced Complication | 48 percentage of participants |
Secondary
Average Number of Line Reversals Per Subject
Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symmetric Tip | Average Number of Line Reversals Per Subject | 6.5 events | Standard Deviation 18.87 |
| Split-tip | Average Number of Line Reversals Per Subject | 8.0 events | Standard Deviation 21.01 |
Secondary
Frequency of Clinician Interventions for Catheter Malfunction and Infection
Average number of times clinician intervention was required for either catheter malfunction or infection
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symmetric Tip | Frequency of Clinician Interventions for Catheter Malfunction and Infection | 8.2 events | Standard Deviation 12.22 |
| Split-tip | Frequency of Clinician Interventions for Catheter Malfunction and Infection | 10.0 events | Standard Deviation 15.89 |
Secondary
Inadequate Flow Rates Requiring Surgical/Radiological Intervention
Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.
Time frame: 35 weeks
Population: Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symmetric Tip | Inadequate Flow Rates Requiring Surgical/Radiological Intervention | 18 events |
| Split-tip | Inadequate Flow Rates Requiring Surgical/Radiological Intervention | 29 events |
Secondary
Primary Failure Rate
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symmetric Tip | Primary Failure Rate | 3.9 percentage of catheters |
| Split-tip | Primary Failure Rate | 4.9 percentage of catheters |
Secondary
Reliability of the Catheter
Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symmetric Tip | Reliability of the Catheter | 90.6 percentage of study visits | Standard Deviation 20.1 |
| Split-tip | Reliability of the Catheter | 86.9 percentage of study visits | Standard Deviation 23.37 |