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Study of the role of taper graft in preventing access-associated steal syndrome in diabetic ESRD patients

Analysis and comparison of two types of ePTFE vascular grafts, straight 6mm vs. taper 4-6 or 4-7 mm in development of access-associated steal syndrome in diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013041212993N1
Enrollment
40
Registered
2013-07-16
Start date
2012-12-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

End stage renal disease. Chronic kidney disease, stage 5

Interventions

Intervention 1: Intervention group: placement of taper 4-6 ePTFE arteriovenous graft as hemodialysis access. Intervention 2: Control group: placement of straight 6mm ePTFE arteriovenous graft as hemod
Treatment - Surgery
Intervention group: placement of taper 4-6 ePTFE arteriovenous graft as hemodialysis access
Control group: placement of straight 6mm ePTFE arteriovenous graft as hemodialysis access

Sponsors

Jondi Shpoor University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion: all the diabetic patients with end stage renal disease which are referred for placement of vascular access for hemodialysis and are not candidates for native AVF due to poor upper extremity superficial veins anatomy Exclusion: deformity, previous fractures or orthopedic operations on wrist and forearm, previous radial-cephalic AV fistula, known vasculitis or Raynaud's phenomenon or other occlusive vascular diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Steal syndrome. Timepoint: First: post-op day 1, Second: after initiation of hemodialysis through graft (second week of graft placement). Method of measurement: History: paresthesis and pain, spontanously or during dialysis.Physical Examination: radial pulse, capillary refilling,ischemia or gangrene of hand.

Secondary

MeasureTime frame
Effect of brachial artery and axillary vein diameters on development of steal syndrome. Timepoint: Intraoperative. Method of measurement: Diameter in mm using scaled vascular dilatator.;Effect of graft flow rate on development of steal syndrome. Timepoint: Post-op day 1 and second week (2 times). Method of measurement: Color Doppler ultrasound, calculation of flow rate in ml/min.;Effect of type and chronicity and complications of diabetes, and also other atherosclerotic vascular diseases and HTN on development of steal syndrom. Timepoint: Pre-op questionnaire. Method of measurement: History and physical examination.;Mean arterial pressure. Timepoint: intraoperative. Method of measurement: In mmHg using Sphygmomanomerer and calculated by formula:mean arterial pressure= Dia BP + (Sys BP-Dia BP) /3.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mansour Alamshah,MD

Department of Surgery,Faculty of Medicine, Jondi Shapoor University of Medical Sciences

mansourseyedalam@gmail.com+98 61 1374 3076

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026