Catheter BlockageNCT04772209
Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters
A study testing Sodium bicarbonate and Heparin in people with Catheter Blockage and Catheter-Related Infections, run by Zonguldak Ataturk State Hospital at 2 sites in Turkey (Türkiye).
Trial summary
In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Catheter Blockage, Catheter-Related Infections, Dialysis Catheter; Thrombosis
- What is being tested?
- Sodium bicarbonate and Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 30 Mar 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over 18 years who assign consent will be included
Who cannot join
- patients less than 18 years of age
- Patients with active arterial or venous thrombosis problems
- Thrombocytopenic patients
- Patients with hypercoagulable states
- Patients with contraindications to heparin usage
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cumhuriyet University Hospital
Sivas, TN, 34762
Zonguldak ataturk state hospital
Zonguldak, TN, 67100
About this study
Official title: Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters
In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.
Read the detailed description
The most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. In acute situations, vascular access is usually provided by non-tunneled catheters. Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. In some patients, there is a handicap of using heparin. In some situations, heparin is not preferred for use. In terms of the probable shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. The main aim of this study is to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed for dialysis. In both arms, the maximum patency and the observed side effects will be recorded. The maximal time used will be recorded. statistical analysis will be planned to compare the two groups.
- Conditions
- Catheter Blockage, Catheter-Related Infections, Dialysis Catheter; Thrombosis, Catheter Infection, Catheter Related Complication, Catheter Dysfunction
- Being tested
- Sodium bicarbonate, Heparin
- Keywords
- catheter lock solution, sodium bicarbonate, heparin, Non-tunneled dialysis catheter
- Medical subject headings
- Catheter-Related Infections, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Dialysis catheter lumen will be filled (locked) by sodium bicarbonate solution. The amount of solution depends on the diameter and length and will be in accordance with the manufacturer's specifications.
HeparinDrug
Dialysis catheter lumen will be filled (locked) by classic heparin. The amount of pure heparin depends on the diameter and length and will be in accordance with the manufacturer's specifications.
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate Arm | Active comparator | In this arm, the catheter lock solution is sodium bicarbonate Receives: Drug: Sodium bicarbonate |
| Heparin arm | Active comparator | In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution) Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first catheter failure (day)
The time from first sucessful dialysis session to the last one (in days)
Measured: 6 months
Total Duration of catheter usage (day)
some patients need only 1-2 dialysis sessions while others may need too many sessions. In some cases a total of three dialysi sessions is whithin 3-4 days while others may need that number in wider range (e.g 10-14 days). Here both number and duraion effect is evaluated
Measured: 6 months
Number of participants with catheter occlusion
The number of cases early catheter
Measured: 6 months
Number of patients with catheter related infection
any catheter related infection(exit site, lumen inection etc) will be recorded
Measured: 6 months
Time of catheter occlusion or failure
catheteres occluded by thrombi will be documented
Measured: 6 months
Causes of premature catheter malfunction
any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)
Measured: 6 months
Secondary outcomes (2)
Total number of dialysis sessions with active patent catheter usage
In some cases intensive treatment is indicated. the effect of frequent usage of catheteres will be evaluated
Measured: 6 months
Number of cases with venous thrombosis
catheters especially femoral have a risk of venous thrombosis, any clincal sign of thrombosis will be recorded. In case of catheter removal doppler ultrasound will be documented.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Catheter BlockageStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bicarbonate vs Heparin group (femoral vs jugular catheter)
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Ataturk State Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University, Sisli Hamidiye Etfal Training and Research Hospital
- Responsible party
- Principal investigator, mahmud islam, Zonguldak Ataturk State Hospital
- Investigators
- MAHMUD M ISLAM, MD, Principal investigator, Zonguldak Ataturk State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772209
- Sponsor's protocol ID
- ZADH-1
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and methods will be available in a paper intended for publication, any materials or data may be available on demand
Publications
El-Hennawy AS, Frolova E, Romney WA. Sodium bicarbonate catheter lock solution reduces hemodialysis catheter loss due to catheter-related thrombosis and blood stream infection: an open-label clinical trial. Nephrol Dial Transplant. 2019 Oct 1;34(10):1739-1745. doi: 10.1093/ndt/gfy388.
PubMed 30668833Islam M. Sodium bicarbonate is a potential alternative to classic heparin as a lock solution for non-tunneled dialysis catheters: a result from the prospective randomized BicarbLock trial. Int Urol Nephrol. 2024 Apr;56(4):1465-1474. doi: 10.1007/s11255-023-03821-9. Epub 2023 Oct 12.
PubMed 37823971
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters
- ClinicalTrials.gov ID
- NCT04772209
- Acronym / sponsor ID
- ZADH-1
- Conditions
- Catheter Blockage, Catheter-Related Infections, Dialysis Catheter; Thrombosis, Catheter Infection, Catheter Related Complication, Catheter Dysfunction
- Keywords
- catheter lock solution, sodium bicarbonate, heparin, Non-tunneled dialysis catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Zonguldak Ataturk State HospitalUniversity, hospital or other
- Collaborators
- Cumhuriyet University, Sisli Hamidiye Etfal Training and Research Hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 26 Feb 2021 (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.
In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.
Detailed description
The most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. In acute situations, vascular access is usually provided by non-tunneled catheters. Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. In some patients, there is a handicap of using heparin. In some situations, heparin is not preferred for use. In terms of the probable shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. The main aim of this study is to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed for dialysis. In both arms, the maximum patency and the observed side effects will be recorded. The maximal time used will be recorded. statistical analysis will be planned to compare the two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bicarbonate vs Heparin group (femoral vs jugular catheter)
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate Arm | Active comparator | Drug: Sodium bicarbonateIn this arm, the catheter lock solution is sodium bicarbonate |
| Heparin arm | Active comparator | Drug: HeparinIn this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over 18 years who assign consent will be included
Key exclusion criteria (5 listed)
- patients less than 18 years of age
- Patients with active arterial or venous thrombosis problems
- Thrombocytopenic patients
- Patients with hypercoagulable states
- Patients with contraindications to heparin usage
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 |
|---|---|---|
| Sodium bicarbonateDialysis catheter lumen will be filled (locked) by sodium bicarbonate solution. The amount of solution depends on the diameter and length and will be in accordance with the manufacturer's specifications. | Drug | Sodium bicarbonate Arm |
| HeparinDialysis catheter lumen will be filled (locked) by classic heparin. The amount of pure heparin depends on the diameter and length and will be in accordance with the manufacturer's specifications. | Drug | Heparin arm |
Primary outcome
Time to first catheter failure (day)
Time frame: 6 months
The time from first sucessful dialysis session to the last one (in days)
Total Duration of catheter usage (day)
Time frame: 6 months
some patients need only 1-2 dialysis sessions while others may need too many sessions. In some cases a total of three dialysi sessions is whithin 3-4 days while others may need that number in wider range (e.g 10-14 days). Here both number and duraion effect is evaluated
Number of participants with catheter occlusion
Time frame: 6 months
The number of cases early catheter
Number of patients with catheter related infection
Time frame: 6 months
any catheter related infection(exit site, lumen inection etc) will be recorded
Time of catheter occlusion or failure
Time frame: 6 months
catheteres occluded by thrombi will be documented
Causes of premature catheter malfunction
Time frame: 6 months
any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)
2 secondary outcomes
Total number of dialysis sessions with active patent catheter usage
Time frame: 6 months
Number of cases with venous thrombosis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 30668833El-Hennawy AS, Frolova E, Romney WA. Sodium bicarbonate catheter lock solution reduces hemodialysis catheter loss due to catheter-related thrombosis and blood stream infection: an open-label clinical trial. Nephrol Dial Transplant. 2019 Oct 1;34(10):1739-1745. doi: 10.1093/ndt/gfy388.
- Derived from this study: PubMed 37823971Islam M. Sodium bicarbonate is a potential alternative to classic heparin as a lock solution for non-tunneled dialysis catheters: a result from the prospective randomized BicarbLock trial. Int Urol Nephrol. 2024 Apr;56(4):1465-1474. doi: 10.1007/s11255-023-03821-9. Epub 2023 Oct 12.
- Individual participant dataSharing planned: Yes. The study protocol and methods will be available in a paper intended for publication, any materials or data may be available on demand
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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.
MAHMUD M ISLAM, MD principal investigator
Zonguldak Ataturk State Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate and Heparin in people with Catheter Blockage and Catheter-Related Infections, run by Zonguldak Ataturk State Hospital at 2 sites in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first catheter failure (day) (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772209, which also lists 2 linked publications.
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 13 Jun 2023.