BacteremiaPhase 4ALLOCKNCT00571259
Prophylactic Antimicrobial Catheter Lock
A Phase 4 study testing Heparin 1000U/mL and 4% Sodium Citrate with Gentamicin 320 mcg/mL in people with Bacteremia, run by Satellite Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacteremia
- What is being tested?
- Heparin 1000U/mL and 4% Sodium Citrate with Gentamicin 320 mcg/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Satellite Healthcare, Inc
Mountain View, California, 94041
About this study
Official title: Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
Read the 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.
- Conditions
- Bacteremia
- Being tested
- Heparin 1000U/mL, 4% Sodium Citrate with Gentamicin 320 mcg/mL
- Keywords
- Sodium citrate, Gentamicin, Prophylaxis, Hemodialysis, Central venous catheter
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin 1000U/mLDrug
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
4% Sodium Citrate with Gentamicin 320 mcg/mLDrug
A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Catheter lock with heparin 1,000 units/mL Receives: Drug: Heparin 1000U/mL |
| 2 | Active comparator | Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4% Receives: Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startSep 2003
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norman Coplon, MD, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571259
- Sponsor's protocol ID
- SR001AL
- Acronym
- ALLOCK
- Status last verified
- Sep 2021
- First submitted
- 10 Dec 2007
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00571259
- Acronym / sponsor ID
- ALLOCK / SR001AL
- Conditions
- Bacteremia
- Keywords
- Sodium citrate, Gentamicin, Prophylaxis, Hemodialysis, Central venous catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Posted 22 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Heparin 1000U/mLCatheter lock with heparin 1,000 units/mL |
| 2 | Active comparator | Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mLCatheter lock with gentamicin 320 micrograms/mL in sodium citrate 4% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin 1000U/mLA volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis | Drug | 1 |
| 4% Sodium Citrate with Gentamicin 320 mcg/mLA volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis | Drug | 2 |
Primary outcome
Rate of Device-related Bacteremia
Time frame: 5 years
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
1 secondary outcome
Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Coplon, MD principal investigator
Satellite Healthcare, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin 1000U/mL and 4% Sodium Citrate with Gentamicin 320 mcg/mL in people with Bacteremia, run by Satellite Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device-related Bacteremia (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.