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Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis (DACAPO)

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ClinicalTrials.gov Identifier: NCT02264964
Recruitment Status : Unknown
Verified October 2014 by Changlin Mei, Shanghai Changzheng Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
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
Information provided by (Responsible Party):
Changlin Mei, Shanghai Changzheng Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Renal Failure Chronic Requiring Hemodialysis Central Venous Catheterization Inadequate Hemodialysis Blood Flow Venous Stenosis Venous Thrombosis Infection Due to Central Venous Catheter Central Venous Catheter Thrombosis Device: GamCath® Procedure: Arteriovenous fistula creation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: internal jugular vein catheterization
900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.
Device: GamCath®
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.
Other Name: radiopaque catheter(11F) polyurethane with curved extension lines

Procedure: Arteriovenous fistula creation
900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
Other Names:
  • Arteriovenous fistulization
  • AVF creation

Experimental: femoral vein catheterization
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.
Device: GamCath®
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
Other Name: radiopaque catheter(11F) polyurethane

Procedure: Arteriovenous fistula creation
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
Other Names:
  • Arteriovenous fistulization
  • AVF creation




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. venous thrombosis [ Time Frame: up to 3 months ]
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.

  6. venous stenosis [ Time Frame: up to 3 months ]
    Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.

  7. 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.


Secondary Outcome Measures :
  1. Long term occurrence of venous stenosis [ Time Frame: 6 months ]
    CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.

  2. Effects on ECG [ Time Frame: From baseline to 6months ]
    ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.

  3. Safety Evaluation [ Time Frame: From baseline to 6months ]
    adverse event or serious adverse event



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic renal failure requiring hemodialysis.
  • No medical history of central vena catheterization.
  • Maintenance hemodialysis after central vena catheterization.
  • Signed informed consent.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264964


Contacts
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Contact: Yiyi Ma, master +8613661679863 dukemm@126.com

Sponsors and Collaborators
Shanghai Changzheng Hospital
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
Investigators
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Principal Investigator: Changlin Mei, master Division of Nephrology, Shanghai ChangZheng Hospital

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Responsible Party: Changlin Mei, Professor, Director, Division of Nephrology, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT02264964     History of Changes
Other Study ID Numbers: CZHKI-HDVA-002
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Changlin Mei, Shanghai Changzheng Hospital:
Hemodialysis
End-Stage Kidney Disease
Central Venous Catheterization
Digital Subtraction Angiography
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic