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 |
| Protocol serial number | NSC-96-2314-B-010-045 |
| Sponsor | National Science Council (Taiwan) |
| Funder | National Science Council (Taiwan) |
- 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
Scientific
No. 201, Sec. 2, Shih-Pai Rd
Taipei
112
Taiwan
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controllled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Current primary outcome measure as of 03/03/2008: |
| Key secondary outcome measure(s) |
Current secondary outcome measure as of 03/03/2008: |
| Completion date | 09/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| 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
112
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
