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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| Zhongda Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GamCath® | Device | Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Inadequate hemodialysis blood flow | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | up to 3 months |
| Central venous catheter thrombosis | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | up to 3 months |
| venous thrombosis | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | up to 3 months |
| venous stenosis | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | 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. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effects on ECG | ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiyi Ma, master | Contact | +8613661679863 | dukemm@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Changlin Mei, master | Division of Nephrology, Shanghai ChangZheng Hospital | Principal Investigator |
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| Sichuan Provincial People's Hospital |
| OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Beijing Haidian Hospital | OTHER |
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|
| Arteriovenous fistula creation | Procedure | 500 patients will undergo AVF creation in either arm for femoral vein catheterization group. |
|
|
| GamCath® | Device | 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 creation | Procedure | 900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group. |
|
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| From baseline to 6months |
| Safety Evaluation | adverse event or serious adverse event | From baseline to 6months |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D056824 | Upper Extremity Deep Vein Thrombosis |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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