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

Venous Thrombosis Clinical Trial

— DACAPO  

Official title:

Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02264964
• Other study ID #: CZHKI-HDVA-002
• 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

• Central Venous Catheter Thrombosis
• Central Venous Catheterization
• Inadequate Hemodialysis Blood Flow
• Infection Due to Central Venous Catheter
• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Venous Stenosis
• Venous Thrombosis

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