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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02264964

Acronym

DACAPO

Enrollment

1400

Registered

2014-10-15

Start date

2015-01-31

Completion date

2017-12-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Keywords

Hemodialysis, End-Stage Kidney Disease, Central Venous Catheterization, Digital Subtraction Angiography

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.

Interventions

DEVICEGamCath®

Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.

PROCEDUREArteriovenous fistula creation

500 patients will undergo AVF creation in either arm for femoral vein catheterization group.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Duration time of non-cuff catheter	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter thrombosis	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous thrombosis	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous stenosis	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Bloodstream infection due to central venous catheter	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter exit site infection	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Inadequate hemodialysis blood flow	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.

Secondary

Measure	Time frame	Description
Effects on ECG	From baseline to 6months	ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.
Safety Evaluation	From baseline to 6months	adverse event or serious adverse event
Long term occurrence of venous stenosis	6 months	CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.

Contacts

Primary ContactYiyi Ma, master

dukemm@126.com+8613661679863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026