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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02264964
Other study ID # CZHKI-HDVA-002
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 23, 2014
Last updated October 9, 2014
Start date January 2015
Est. completion date December 2017

Study information

Verified date October 2014
Source Shanghai Changzheng Hospital
Contact Yiyi Ma, master
Phone +8613661679863
Email dukemm@126.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1400
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
GamCath®
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
Procedure:
Arteriovenous fistula creation
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
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.
Procedure:
Arteriovenous fistula creation
900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.

Locations

Country Name City State
n/a

Sponsors (7)

Lead Sponsor Collaborator
Shanghai Changzheng Hospital Beijing Haidian Hospital, First Affiliated Hospital of Zhejiang University, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Dalian Medical University, Zhongda Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Bloodstream infection due to central venous catheter Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months Yes
Primary Central venous catheter exit site infection Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months Yes
Primary Inadequate hemodialysis blood flow Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months No
Primary Central venous catheter thrombosis Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months No
Primary venous thrombosis Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months Yes
Primary venous stenosis Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months Yes
Primary Duration time of non-cuff catheter Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. up to 3 months No
Secondary Long term occurrence of venous stenosis CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months. 6 months Yes
Secondary Effects on ECG ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months. From baseline to 6months Yes
Secondary Safety Evaluation adverse event or serious adverse event From baseline to 6months Yes
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