The study of the effect of far infrared therapy on the inflammatory markers and the haemodynamic parameters of vascular access in patients with end stage renal disease

Completed

• Conditions: Stenosis of arteriovenous fistula; Circulatory System; Arteriovenous fistula

• Registration Number: ISRCTN53992566
• Lead Sponsor: ational Science Council (Taiwan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Current inclusion criteria as of 03/03/2008:
HD Patients:
1. Are receiving four hours of maintenance haemodialysis (HD) therapy three times weekly for at least six months
2. Are using a AVF or AV graft as the present vascular access for more than six months, without interventions within the previous three months

Both HD and non-HD ESRD patients:
1. Are without fever or clinical signs of active infection
2. Creation of AVF with the standardised surgical procedures of venous end-to-arterial side anastomosis or AV graft with loop conformation by cardiovascular surgeons in our hospital in the upper extremity
3. Are between 20 and 80 years of age, both genders

Previous inclusion criteria:
Patients:
1. Are receiving 4 hours of maintenance haemodialysis (HD) therapy three times weekly for at least six months
2. Are using a native AVF as the present vascular access for more than six months, without interventions within the last three months
3. Are without fever or clinical signs of active infection
4. Creation of AVF by cardiovascular surgeons in our hospital with the standardised surgical procedures of venous end-to-arterial side anastomosis in the upper extremity
5. Are between 20 and 80 years of age, both genders

Exclusion Criteria

Current exclusion criteria as of 03/03/2008:
Patients use Perm catheter as vascular access for haemodialysis.

Previous exclusion criteria:
Patients use AV graft or Perm catheter as vascular access for haemodialysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 03/03/2008:<br>Unassisted patency of vascular access.<br><br>Previous primary outcome measures:<br>1. Soluble ICAM-1 and VCAM-1 by specific enzyme-linked immunosorbent assay (ELISA) (Diaclone, Besançon, France) <br>2. High sensitivity C-reactive protein (hsCRP)<br><br>Blood samples will be collected every three months for a study period of one year.

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measure as of 03/03/2008:<br>1. Blood samples were analysed for the following items every three months: <br>1.1. Soluble intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) <br>1.2. High sensitivity C-reactive protein (hsCRP)<br>2. Haemodynamic parameters (access flow, cardiac output and total peripheral resistance) will be measured by HD-02 monitor every three months in HD patients and by Doppler ultrasonography in non-HD ESRD patients<br><br>Previous secondary outcome measure:<br>Access blood flow; blood samples will be collected every three months for a study period of one year.