NCT02272374

Brief Summary

The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

September 23, 2014

Last Update Submit

October 20, 2014

Conditions

End Stage Renal Disease

Keywords

HemodialysisArteriovenous fistulaTunneled cuffed catheterArteriovenous graftElderlyVery elderly

Outcome Measures

Primary Outcomes (3)

  • The patency rate of vascular access

    Including primary and secondary patency rate.Blood flow can be above 500 mL/min in a mature arteriovenous fistula by ultrasound scan and 4 times of body weight (Kg\*4 mL/min) in a arteriovenous graft or tunneled cuffed catheter in dialysis practice.

    2 years

  • Effect of vascular access construction on ventricular volumes and left ventricular remodeling

    Assessed by doppler echocardiography

    2 years

  • Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function

    Cognitive functions are assessed by psychic and autonomy scores

    2 years

Secondary Outcomes (4)

  • Complications of vascular access

    2 years

  • Cost-effectiveness of different vascular access

    2 years

  • Hospitalization rate due to vascular access.

    2 years

  • Mortality due to vascular access

    2 years

Study Arms (6)

e-AVF group

EXPERIMENTAL

120 elderly with end stage renal disease will undergo AVF creation.

Procedure: AVF creation

e-TCC group

EXPERIMENTAL

120 elderly with end stage renal disease will undergo TCC placement.

Procedure: TCC placement

e-AVG group

EXPERIMENTAL

60 elderly with end stage renal disease will undergo AVG creation.

Procedure: AVG creation

ve-AVF group

EXPERIMENTAL

80 very elderly with end stage renal disease will undergo AVF creation.

Procedure: AVF creation

ve-TCC group

EXPERIMENTAL

80 very elderly with end stage renal disease will undergo TCC placement.

Procedure: TCC placement

ve-AVG group

EXPERIMENTAL

40 very elderly with end stage renal disease will undergo AVG creation.

Procedure: AVG creation

Interventions

AVF creationPROCEDURE
Also known as: Arteriovenous fistula creation
e-AVF groupve-AVF group
TCC placementPROCEDURE
Also known as: Tunneled cuffed catheter placement
e-TCC groupve-TCC group
AVG creationPROCEDURE
Also known as: Arteriovenous graft creation
e-AVG groupve-AVG group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The elderly and very elderly with end stage renal disease.
  • Estimated glomerular filtration rate (eGFR) \<20ml/min\*1.73m2
  • All study subjects agree to participate in the study and provide written informed consent.

You may not qualify if:

  • Patients' life expectancy is less than 2 years.
  • Mental illness that makes the patients unable to complete the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, 200003, China

Location

MeSH Terms

Conditions

Kidney Failure, ChronicArteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Officials

  • Changlin Mei, master

    Division of Nephrology, Shanghai ChangZheng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohong Hu, master

CONTACT

+8615026520819huxiaohong8305@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director, Division of Nephrology

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations

CN(1)