Is functional iron deficiency the cause of anaemia in haemodialysis patients with dialysis catheters? A randomised controlled study
| ISRCTN | ISRCTN73108732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73108732 |
| Secondary identifying numbers | N0436121434 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 Paul Laboi
Scientific
Scientific
Department of Renal Medicine
Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Is functional iron deficiency the cause of anaemia in haemodialysis patients with dialysis catheters? A randomised controlled study |
| Study objectives | To confirm the presence of functional iron deficiency in iron replete haemodialysis patients with dialysis catheters. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Haemodialysis |
| Intervention | Randomised controlled trial. Random allocation to: 1. Treatment one 2. Treatment two |
| Intervention type | Other |
| Primary outcome measure | 1. To determine the relationship between functional iron deficiency and EPO resistance. 2. Serum ferritin 3. iron 4. transferrin saturation 5. percentage of hypochromic erthrocytes 6. haematocrit 7. reticulocyte count 8. reticulocyte haemoglobin concentration 9. serum C-r |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2002 |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Haemodialysis patients over 18 years of age on dialysis treatment for at least 3 months 2. Stable haemodialysis patients dialyzing with a central venous catheter on erythropoietin (EPO) therapy |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
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 |
Editorial Notes
26/01/2016: no publications found on PubMed.
