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

ISRCTN	ISRCTN53992566
DOI	https://doi.org/10.1186/ISRCTN53992566
Secondary identifying numbers	NSC-96-2314-B-010-045

Submission date: 20/11/2007
Registration date: 21/02/2008
Last edited: 16/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chih-Ching Lin
Scientific

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

Study information

Study design	Randomised, controllled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Ethics approval received from the Institutional Review Board (IRB) of Taipei Veterans General Hospital on the 19th November 2007 (ref: 96-10-11A).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	08/10/2007
Completion date	09/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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).
Key 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
Key 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.
Date of first enrolment	08/10/2007
Date of final enrolment	09/10/2008

Locations

Countries of recruitment

China
Taiwan

Study participating centre

No. 201, Sec. 2, Shih-Pai Rd

Taipei
112
Taiwan

Sponsor information

National Science Council (Taiwan)
Government

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

Website	http://web.nsc.gov.tw/
"ROR"	https://ror.org/02kv4zf79

Funders

Funder type

Government

National Science Council (Taiwan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan