CClinicalTrials.gg
Status unknownNCT02259296TACTICUpdated Oct 8, 2014

Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure

An interventional study of Lower eGFR for AVF construction and Higher eGFR for AVF construction in Renal Failure, Chronic, sponsored by Shanghai Changzheng Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-08.

Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,200
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The timing for arteriovenous fistula (AVF) creation and its effect on target organs in patients with chronic renal failure will be investigated by multicenter prospective cohort. Lower estimated glomerular filtration rate (eGFR) patients (eGFR\<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<15ml/min 1.73m2 for diabetic kidney disease) and higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF creation. Maturation rate and time of AVF will be followed up in 3 months; primary and secondary patency rate of AVF, AVF construction on cardiac structure, function, encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF creation

02

Conditions studied

03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 2,200 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with chronic renal failure, without AVF creation;
  • Estimated glomerular filtration rate (eGFR) \<15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<20ml/min 1.73m2 for diabetic kidney disease;
  • All study subjects must agree to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement;
  • Contraindications to AVF construction:

    • Allen's Test is positive, or arterial diameter\<2 mm; venous diameter\<2.5 mm or venous occlusion/stenosis.
    • Local infection.
  • Have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ).
  • Mental illness that makes the patients unable to complete the trial.
  • Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,200 participants (estimated)

Study arms

  • Experimental
    Lower eGFR for AVF creation

    Procedure: Lower eGFR for AVF construction

  • Active comparator
    Higher eGFR for AVF creation

    Procedure: Higher eGFR for AVF construction

Interventions

  • ProcedureLower eGFR for AVF construction

    Lower eGFR patients (eGFR\<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction

    Also known as: late AVF construction

  • ProcedureHigher eGFR for AVF construction

    Higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction

    Also known as: early AVF construction

06

What researchers measure

Primary outcomes

  1. Maturation rate of AVF

    Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm

    Time frame: 3 months

  2. Primary and secondary patency rate of AVF

    Assessed by duplex ultrasound

    Time frame: 2 years

Secondary outcomes

  1. Maturation time of AVF

    Assessed by duplex ultrasound

    Time frame: 3 months

  2. Complications of AVF

    Assessed by duplex ultrasound

    Time frame: 2 years

  3. AVF creation on ventricular volumes and left ventricular remodeling

    Assessed by doppler echocardiography

    Time frame: 2 years

  4. AVF creation on AVF creation on brain MRI and cognitive functions

    Cognitive functions are assessed by psychic and autonomy scores

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02259296
Lead sponsor
Shanghai Changzheng Hospital
Collaborators
First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
Responsible party
Changlin Mei (Professor, Director, Division of Nephrology, Shanghai Changzheng Hospital) — Principal investigator
First posted
Oct 8, 2014
Start date
Jan 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Oct 8, 2014

Study contacts

Xiang Gao
Contact
gaoxiang43100636@163.com
+862181885397
Changlin Mei
principal investigator · Division of Nephrology, Changzheng Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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