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The purpose of this clinical trial is to compare the longevity of two dialysis catheters.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | symmetric tip catheter |
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| 2 | Active Comparator | conventional split-tip catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symmetric Tip Catheter | Device | Dialysis catheter |
| |
| Conventional Split-tip Catheter |
| Measure | Description | Time Frame |
|---|---|---|
| First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 30 days |
| First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 60 days |
| First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 245 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 35 weeks |
| Average Number of Line Reversals Per Subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klemens B Meyer, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Associates, P.C. | Birmingham | Alabama | 35211 | United States | ||
| Southwest Kidney Institute |
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Symmetric Tip | symmetric tip hemodialysis catheter |
| FG001 | Split-tip | split-tip hemodialysis catheter |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device |
Dialysis Catheter |
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Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments |
| 35 Weeks |
| Frequency of Clinician Interventions for Catheter Malfunction and Infection | Average number of times clinician intervention was required for either catheter malfunction or infection | 35 Weeks |
| 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. | First dialysis session with study catheter |
| Reliability of the Catheter | Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min. | 35 Weeks |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| SUNY Stony Brook Medical Center | Stony Brook | New York | 11794 | United States |
| Eastern Nephrology Associates | Greenville | North Carolina | 27834 | United States |
| Eastern Nephrology Associates | New Bern | North Carolina | 28562 | United States |
| Boice-Willis Clinic | Rocky Mount | North Carolina | 27804 | United States |
| Dialysis Access Group of Wake Forest University, LLC | Winston-Salem | North Carolina | 27101 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Nephrology Associates - Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Columbia Nephrology Associates | Columbia | South Carolina | 29203 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Symmetric Tip | symmetric tip hemodialysis catheter |
| BG001 | Split-tip | split-tip hemodialysis catheter |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 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. | Posted | Number | percentage of participants | 30 days |
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| 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'. | Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized. | Posted | Number | events | 35 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 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. | Posted | Number | percentage of participants | 60 days |
|
| ||||||||||||||||||||||||||||||
| Primary | First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 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. | Posted | Number | percentage of participants | 245 days |
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| Secondary | Average Number of Line Reversals Per Subject | Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments | 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. | Posted | Mean | Standard Deviation | events | 35 Weeks |
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| Secondary | Frequency of Clinician Interventions for Catheter Malfunction and Infection | Average number of times clinician intervention was required for either catheter malfunction or infection | 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. | Posted | Mean | Standard Deviation | events | 35 Weeks |
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| 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. | 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. | Posted | Number | percentage of catheters | First dialysis session with study catheter |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of study visits | 35 Weeks |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symmetric Tip | symmetric tip hemodialysis catheter | 11 | 303 | 0 | 303 | ||
| EG001 | Split-tip | split-tip hemodialysis catheter | 4 | 296 | 0 | 296 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations |
| |||
| Catheter Infection | Infections and infestations |
| |||
| Catheter-related bacteremia | Infections and infestations |
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| Catheter-related blood stream infection (CRBSI) | Infections and infestations |
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| Exit site infection | Infections and infestations |
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| Fever of unknown origin, bacteremia | Infections and infestations |
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| Gram negative bacteremia | Infections and infestations |
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| Infection | Infections and infestations |
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| Infection, permcath associated bacteremia | Infections and infestations |
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| Methicillin resistant staphylococcus aureus-sepsis (MRSA) | Infections and infestations |
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| Pulmonary embolism (PE) | Vascular disorders |
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| Sepsis | Infections and infestations |
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| Staph aureus bacteremia | Infections and infestations |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Klemens B. Meyer | Tufts Medical Center | 617-636-9421 | kmeyer@tuftsmedicalcenter.org |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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