Bacteremia
Conditions
Keywords
Sodium citrate, Gentamicin, Prophylaxis, Hemodialysis, Central venous catheter
Brief summary
This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
Detailed description
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.
Interventions
DRUGHeparin 1000U/mL
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
DRUG4% Sodium Citrate with Gentamicin 320 mcg/mL
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
Sponsors
Satellite Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access. * Must be at least 18 years old * Compliant with a dialysis treatment schedule * Plans to continue hemodialysis treatment and follow-up at the investigational site * Must be able to care for the exit site independently or have someone who is able to care for the site for them * Must be able to sign the informed consent document
Exclusion criteria
* The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred * Active exit site or tunnel infection * Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening * Known to have antibodies to heparin * Allergy to pork heparin * Allergy to gentamicin * Subject is pregnant * Known intravenous drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device-related Bacteremia | 5 years | Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow | 5 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 148 |
| 2: Gentamicin Lock 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 | 155 |
| Total | 303 |
Baseline characteristics
| Characteristic | 1: Heparin Lock | Total | 2: Gentamicin Lock |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 16.8 | 63.1 years STANDARD_DEVIATION 14.8 | 63.4 years STANDARD_DEVIATION 15.6 |
| Catheter site External Jugular | 12 Participants | 24 Participants | 12 Participants |
| Catheter site Femoral | 1 Participants | 3 Participants | 2 Participants |
| Catheter site Internal Jugular | 104 Participants | 217 Participants | 113 Participants |
| Catheter site Subclavian | 6 Participants | 13 Participants | 7 Participants |
| Catheter site Unknown | 25 Participants | 46 Participants | 21 Participants |
| Diabetes | 86 Participants | 171 Participants | 85 Participants |
| Dialysis vintage in Months | 44.3 months | 43.32 months | 42.4 months |
| Incident Catheters | 15 Participants | 20 Participants | 5 Participants |
| Region of Enrollment United States | 148 participants | 303 participants | 155 participants |
| Sex: Female, Male Female | 81 Participants | 157 Participants | 76 Participants |
| Sex: Female, Male Male | 67 Participants | 146 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 25 / 148 | 27 / 155 |
| other Total, other adverse events | 0 / 148 | 0 / 155 |
| serious Total, serious adverse events | 25 / 148 | 27 / 155 |
Outcome results
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
Time frame: 5 years
Population: Episodes of catheter related infections in each group throughout the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1: Heparin Lock | Rate of Device-related Bacteremia | 30 Number of infections |
| 2: Gentamicin Lock | Rate of Device-related Bacteremia | 11 Number of infections |
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.
Time frame: 5 years
Population: tPA use/1,000 catheter-days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1: Heparin Lock | Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow | 3.42 tPA use/1,000 catheter-days |
| 2: Gentamicin Lock | Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow | 2.36 tPA use/1,000 catheter-days |