Condition category
Circulatory System
Date applied
20/11/2007
Date assigned
21/02/2008
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chih-Ching Lin

ORCID ID

Contact details

No. 201
Sec. 2
Shih-Pai Rd
Taipei
112
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NSC-96-2314-B-010-045

Study information

Scientific title

Acronym

Study hypothesis

Please note that as of 03/03/2008 this trial record was extensively amended. Most of the changes to this record can be found in the relevant field, under the date on which the amendment was made. The following changes have also taken place:
1. At the time of amendment, the above title was changed from 'The study of the effect of far infrared therapy on the inflammatory markers and the haemodynamic parameters of vascular access in haemodialysis patients' to the above title
2. The anticipated end date of this trial was extended to 09/10/2008; the previous anticipated end date was 19/10/2007
3. The number of participants has been increased to 200 in total; the previous number of participants was 20

Current hypothesis as of 03/03/2008:
In this study, we evaluated whether there is an interaction between far infrared radiation (FIR) and heme oxygenase-1 (HO-1) in regulating vascular inflammation. FIR therapy may exert an anti-inflammatory effect via the induction of HO-1. The potential effect of FIR therapy to inhibit inflammation may play a critical role in preserving blood flow and patency of arteriovenous fistulas (AVFs) in patients with end stage renal disease (ESRD).

Previous hypothesis:
In this study, we evaluated whether there is an interaction between far infrared radiation (FIR) and heme oxygenase-1 (HO-1) in regulating vascular inflammation. FIR therapy may exert an anti-inflammatory effect via the induction of HO-1. The potential effect of FIR therapy to inhibit inflammation may play a critical role in preserving blood flow and patency of arteriovenous fistulas (AVFs) in haemodialysis patients.

Ethics approval

Ethics approval received from the Institutional Review Board (IRB) of Taipei Veterans General Hospital on the 19th November 2007 (ref: 96-10-11A).

Study design

Randomised, controllled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Stenosis of arteriovenous fistula

Intervention

Current interventions as of 03/03/2008:
HD patients:
40 minutes of far-infrared therapy during the second and the subsequent sessions of haemodialysis three times a week (TIW) for a duration of one year.

Non-HD ESRD patients:
40 minutes of far-infrared therapy three times a week (TIW) for a duration of three months.

Previous interventions:
One session of 40 minutes of far-infrared therapy during the second session of haemodialysis.

Blood samples were analysed for serum:
1. Soluble intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1)
2. High sensitivity C-reactive protein (hsCRP)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Current primary outcome measure as of 03/03/2008:
Unassisted patency of vascular access.

Previous primary outcome measures:
1. Soluble ICAM-1 and VCAM-1 by specific enzyme-linked immunosorbent assay (ELISA) (Diaclone, Besançon, France)
2. High sensitivity C-reactive protein (hsCRP)

Blood samples will be collected every three months for a study period of one year.

Secondary outcome measures

Current secondary outcome measure as of 03/03/2008:
1. Blood samples were analysed for the following items every three months:
1.1. Soluble intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1)
1.2. High sensitivity C-reactive protein (hsCRP)
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

Previous secondary outcome measure:
Access blood flow; blood samples will be collected every three months for a study period of one year.

Overall trial start date

08/10/2007

Overall trial end date

09/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 HD patients (50 on FIR and 50 controls) and 100 non-HD ESRD patients (50 on FIR and 50 controls).

Participant 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.

Recruitment start date

08/10/2007

Recruitment end date

09/10/2008

Locations

Countries of recruitment

China, Taiwan

Trial participating centre

No. 201, Sec. 2, Shih-Pai Rd
Taipei
112
Taiwan

Sponsor information

Organisation

National Science Council (Taiwan)

Sponsor details

No. 106
Ho Ping E. Road
Sec.2
10622
Taipei
112
Taiwan

Sponsor type

Government

Website

http://web.nsc.gov.tw/

Funders

Funder type

Government

Funder name

National Science Council (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes