Hemodialysis Catheter InfectionNCT03425448
Neutrolin Versus Heparin for Locking Hemodialysis Catheters
A study testing Heparin and Neutrolin in people with Hemodialysis Catheter Infection and Catheter Thrombosis, run by King Abdullah International Medical Research Center.
Trial summary
Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Catheter Infection, Catheter Thrombosis
- What is being tested?
- Heparin and Neutrolin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2019to 4 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New hemodialysis catheter
- Subject who will need chronic hemodialysis at least twice/week
- Subject likely to require for at least 120 days
- Subject or relative is likely to understand the nature of the study and sign the consent
- Age 18 years and older
Who cannot join
- Subject with unstable malignancy
- Subject with liver cirrhosis with encephalopathy
- Subject know to have allergy to heparin, citrate or traoulidine
- Documented history of arterial thrombosis or known to have hypercoagulable state
- Subjects with active skin infections and ulcers
About this study
Official title: Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial
Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.
Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.
This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.
- Being tested
- Heparin, Neutrolin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Heparin hemodialysis catheter lock solution
NeutrolinDevice
Neutrolin hemodialysis catheter lock
| Study group | Role | What they receive |
|---|---|---|
| Heparin group | Active comparator | Not described Receives: Drug: Heparin |
| Neotrolin Group | Experimental | Not described Receives: Device: Neutrolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
Rate of hemodialysis catheter in each study arm
Measured: 18 month
Secondary outcomes (1)
Proportion of hemodialysis catheters with poor flow due to thrombosis
Rate of catheter dysfunction in each group
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start4 Apr 2019 (estimated)
- Primary completion4 Oct 2020 (estimated)
- Study completion4 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Catheter InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multi-center, double-blind, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mubarak Al Abdalla, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425448
- Sponsor's protocol ID
- RC17/083/R
- Status last verified
- Mar 2019
- First submitted
- 25 Jan 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03425448
- Acronym / sponsor ID
- RC17/083/R
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 4 Apr 2019 (estimated)
- Primary completion
- 4 Oct 2020 (estimated)
- Study completion
- 4 Apr 2021 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.
Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.
This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Heparin group | Active comparator | Drug: Heparin |
| Neotrolin Group | Experimental | Device: Neutrolin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New hemodialysis catheter
- Subject who will need chronic hemodialysis at least twice/week
- Subject likely to require for at least 120 days
- Subject or relative is likely to understand the nature of the study and sign the consent
- Age 18 years and older
Key exclusion criteria (5 listed)
- Subject with unstable malignancy
- Subject with liver cirrhosis with encephalopathy
- Subject know to have allergy to heparin, citrate or traoulidine
- Documented history of arterial thrombosis or known to have hypercoagulable state
- Subjects with active skin infections and ulcers
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 |
|---|---|---|
| HeparinHeparin hemodialysis catheter lock solution | Drug | Heparin group |
| NeutrolinNeutrolin hemodialysis catheter lock | Device | Neotrolin Group |
Primary outcome
Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
Time frame: 18 month
Rate of hemodialysis catheter in each study arm
1 secondary outcome
Proportion of hemodialysis catheters with poor flow due to thrombosis
Time frame: 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin and Neutrolin in people with Hemodialysis Catheter Infection and Catheter Thrombosis, run by King Abdullah International Medical Research Center.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days) (time frame: 18 month). 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 5 Mar 2019.