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This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Catheter lock with heparin 1,000 units/mL |
|
| 2 | Active Comparator | Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin 1000U/mL | Drug | A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Device-related Bacteremia | Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow | The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Coplon, MD | Satellite Healthcare, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satellite Healthcare, Inc | Mountain View | California | 94041 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Heparin Lock | Dialysis Catheter locked with heparin 1,000 units/mL. Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
| FG001 | 2: Gentamicin Lock | Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%. 4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All adult patients with either newly placed or existing tunneled cuffed catheters were eligible for enrollment. Patients were excluded if they had an active exit-site or tunnel infection or other systemic or localized infection that was unresponsive to antibiotic therapy and/or was life-threatening. Eligible patients were randomly assigned 1:1 to treatment or control groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Heparin Lock | Dialysis catheter locked with heparin 1,000 units/mL post-dialysis. Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
| BG001 | 2: Gentamicin Lock |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Device-related Bacteremia | Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection | Episodes of catheter related infections in each group throughout the study. | Posted | Number | Number of infections | 5 years |
|
5 years
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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 | 1: Heparin Lock | Dialysis Catheter locked with heparin 1,000 units/mL. Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ESRD Related Death | Renal and urinary disorders | Systematic Assessment | Serious adverse events were deaths of dialysis subjects which were related to ESRD or the subject's comorbid conditions, not study related. |
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The requirement for dialysis facility staff to prepare the treatment intervention prevented a completely blinded study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Veronica Legg, MS: Director of Research Business | Satellite Healthcare, Inc. | 360-607-6892 | leggv@satellitehealth.com |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D000077559 | Sodium Citrate |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D019343 | Citric Acid |
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| 4% Sodium Citrate with Gentamicin 320 mcg/mL | Drug | A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
|
Dialysis catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% post-dialysis. 4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes | Percent of subjects in each cohort who were diabetic. | Count of Participants | Participants |
|
| Dialysis vintage in Months | The number of months the subject has been on hemodialysis. | Median | Full Range | months |
|
| Incident Catheters | Count of Participants | Participants |
|
| Catheter site | Count of Participants | Participants |
|
|
|
| Secondary | Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow | The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting. | tPA use/1,000 catheter-days | Posted | Number | tPA use/1,000 catheter-days | 5 years |
|
|
|
| 25 |
| 148 |
| 25 |
| 148 |
| 0 |
| 148 |
| EG001 | 2: Gentamicin Lock | Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%. 4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis | 27 | 155 | 27 | 155 | 0 | 155 |
|
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| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002951 |
| Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |