Renal Failure Chronic Requiring HemodialysisDACAPONCT02264964
Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis
A study testing GamCath® and Arteriovenous fistula creation in people with Renal Failure Chronic Requiring Hemodialysis and Central Venous Catheterization, run by Shanghai Changzheng Hospital.
Trial summary
The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis, Central Venous Catheterization, Inadequate Hemodialysis Blood Flow
- What is being tested?
- GamCath® and Arteriovenous fistula creation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- 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
- Chronic renal failure requiring hemodialysis.
- No medical history of central vena catheterization.
- Maintenance hemodialysis after central vena catheterization.
- Signed informed consent.
Who cannot join
- Had been performed central venous puncture or catheterization before.
- Can not use heparin.
- Refused to sign the informed consent.
- Advanced cancer patients.
- With or will take arteriovenous fistula surgery in right arm.
- Other inappropriate situation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.
- Conditions
- Renal Failure Chronic Requiring Hemodialysis, Central Venous Catheterization, Inadequate Hemodialysis Blood Flow, Venous Stenosis, Venous Thrombosis, Infection Due to Central Venous Catheter
- Being tested
- GamCath®, Arteriovenous fistula creation
- Keywords
- Hemodialysis, End-Stage Kidney Disease, Central Venous Catheterization, Digital Subtraction Angiography
- Medical subject headings
- Venous Thrombosis, Upper Extremity Deep Vein Thrombosis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamCath®Device
Also called radiopaque catheter(11F) polyurethane
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
Arteriovenous fistula creationProcedure or surgery
Also called Arteriovenous fistulization, AVF creation
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
GamCath®Device
Also called radiopaque catheter(11F) polyurethane with curved extension lines
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.
Arteriovenous fistula creationProcedure or surgery
Also called Arteriovenous fistulization, AVF creation
900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
| Study group | Role | What they receive |
|---|---|---|
| internal jugular vein catheterization | Experimental | 900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation. Receives: Device: GamCath®; Procedure: Arteriovenous fistula creation |
| femoral vein catheterization | Experimental | 500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation. Receives: Device: GamCath®; Procedure: Arteriovenous fistula creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodstream infection due to central venous catheter
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
Central venous catheter exit site infection
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
Inadequate hemodialysis blood flow
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
Central venous catheter thrombosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
venous thrombosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
venous stenosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
Duration time of non-cuff catheter
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Measured: up to 3 months
Secondary outcomes (3)
Long term occurrence of venous stenosis
CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.
Measured: 6 months
Effects on ECG
ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.
Measured: From baseline to 6months
Safety Evaluation
adverse event or serious adverse event
Measured: From baseline to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- Responsible party
- Principal investigator, Changlin Mei, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, master, Principal investigator, Division of Nephrology, Shanghai ChangZheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264964
- Sponsor's protocol ID
- CZHKI-HDVA-002
- Acronym
- DACAPO
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02264964
- Acronym / sponsor ID
- DACAPO / CZHKI-HDVA-002
- Conditions
- Renal Failure Chronic Requiring Hemodialysis, Central Venous Catheterization, Inadequate Hemodialysis Blood Flow, Venous Stenosis, Venous Thrombosis, Infection Due to Central Venous Catheter
- Keywords
- Hemodialysis, End-Stage Kidney Disease, Central Venous Catheterization, Digital Subtraction Angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- 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.
The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internal jugular vein catheterization | Experimental | Device: GamCath®, Procedure: Arteriovenous fistula creation900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation. |
| femoral vein catheterization | Experimental | Device: GamCath®, Procedure: Arteriovenous fistula creation500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic renal failure requiring hemodialysis.
- No medical history of central vena catheterization.
- Maintenance hemodialysis after central vena catheterization.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Had been performed central venous puncture or catheterization before.
- Can not use heparin.
- Refused to sign the informed consent.
- Advanced cancer patients.
- With or will take arteriovenous fistula surgery in right arm.
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 |
|---|---|---|
| GamCath®Also: radiopaque catheter(11F) polyurethaneUsing non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein. | Device | femoral vein catheterization |
| Arteriovenous fistula creationAlso: Arteriovenous fistulization, AVF creation500 patients will undergo AVF creation in either arm for femoral vein catheterization group. | Procedure or surgery | femoral vein catheterization |
| GamCath®Also: radiopaque catheter(11F) polyurethane with curved extension linesUsing non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein. | Device | internal jugular vein catheterization |
| Arteriovenous fistula creationAlso: Arteriovenous fistulization, AVF creation900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group. | Procedure or surgery | internal jugular vein catheterization |
Primary outcome
Bloodstream infection due to central venous catheter
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter exit site infection
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Inadequate hemodialysis blood flow
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter thrombosis
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous thrombosis
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous stenosis
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Duration time of non-cuff catheter
Time frame: up to 3 months
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
3 secondary outcomes
Long term occurrence of venous stenosis
Time frame: 6 months
Effects on ECG
Time frame: From baseline to 6months
Safety Evaluation
Time frame: From baseline to 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Related trials for Renal Failure Chronic Requiring Hemodialysis
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
Not yet recruitingObservational study
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
Coronary Artery Calcification, Cardiovascular Risk
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Active, not recruiting
DisTal Arterio-Venous Fistula Feasibility
End-Stage Renal Disease Requiring Haemodialysis
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.
Changlin Mei, master principal investigator
Division of Nephrology, Shanghai ChangZheng Hospital
Questions about this trial
What is this clinical trial studying?
A study testing GamCath® and Arteriovenous fistula creation in people with Renal Failure Chronic Requiring Hemodialysis and Central Venous Catheterization, run by Shanghai Changzheng Hospital.
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 4 inclusion and 6 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 15 Oct 2014. 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?
Contact Yiyi Ma, master (+8613661679863, dukemm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloodstream infection due to central venous catheter (time frame: up to 3 months). The study lists 7 primary outcomes in all. 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 15 Oct 2014.