Trials / Unknown
UnknownNCT02264964
Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis
Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,400 (estimated)
- Sponsor
- Shanghai Changzheng Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2017-12-01
- Completion
- 2017-12-01
- First posted
- 2014-10-15
- Last updated
- 2014-10-15
Source: ClinicalTrials.gov record NCT02264964. Inclusion in this directory is not an endorsement.