Scandinavian Prospective Randomised Outcome Study of Hemofiltration and Hemodialysis in Incident Dialysis Patients
| ISRCTN | ISRCTN83264534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83264534 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/03/2006
- Registration date
- 27/04/2006
- Last edited
- 31/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Anders Alvestrand
Scientific
Scientific
Department of Clinical Science
Intervention and Technology
Karolinska Institutet
Stockholm
S 141 86
Sweden
| Phone | +46 (0)858582656 |
|---|---|
| anders.alvestrand@klinvet.ki.se |
Study information
| Study design | Prospective, randomised, controlled, parallel group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PROFIL |
| Study objectives | As compared with hemodialysis (HD), on-line, predilution hemofiltration (HF) reduces the development of left ventricular hypertrophy (LVH), decreases overall morbidity, and retards the loss of residual renal function in incident dialysis patients |
| Ethics approval(s) | Approved by the Karolinska Institute Ethics Review Board 29/12/1999, reference number: 99-292 |
| Health condition(s) or problem(s) studied | End stage renal disease patients starting dialysis treatment |
| Intervention | Two different modes of dialysis, conventional hemodialysis (HD) versus hemofiltration (HF) |
| Intervention type | Other |
| Primary outcome measure | The objective of this study is to compare the effect of treatment with pre-dilution HF and HD, respectively, on left ventricular mass index (LVMI) during 1 to a maximum of 3 years follow up |
| Secondary outcome measures | To compare the effect of HF and HD with respect to: 1. Mortality (all causes) 2. Hospitalisation (number of occasions, total number of days in hospital) 3. Blood pressure (antihypertensive drug index) 4. Dose of recombinant human erythropoietin (rHuEPO) needed to keep hemoglobin at target level 5. Infections (antibiotic drug index) 6. Serum lipids 7. Patients subjective evaluation of intra- and inter-dialytic symptoms 8. Residual renal function 9. Cost effectiveness |
| Overall study start date | 15/05/2000 |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Key inclusion criteria | 1. Male and female patients with chronic renal failure 2. Age ≥20 and ≤80 years 3. Dialysis treatment <3 months 4. Expected time in HD at treatment site >1 year |
| Key exclusion criteria | 1. History of myocardial infarction within 3 months 2. Unstable angina 3. Severe cardiac valvular disease 4. Severe cardiac failure (New York Heart Association [NYHA] III-IV) 5. Disseminated malignancy 6. Expected time in hemodialysis <1 year 7. Participation in another study, which may interfere with the present study 8. Unwillingness to undergo the investigations and follow-up required in the protocol 9. Access to the circulation by central venous catheter >3 months 10. Body weight ≥100 kg |
| Date of first enrolment | 15/05/2000 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- Denmark
- Sweden
Study participating centre
Department of Clinical Science
Stockholm
S 141 86
Sweden
S 141 86
Sweden
Sponsor information
Gambro Corporate Research (Sweden)
Industry
Industry
c/o Ingrid Ledebo
Gambro Corporate Research
Box 10101
Lund
S-220 10
Sweden
| Phone | +46 (0)46 16 91 76 |
|---|---|
| ingrid.ledebo@gambro.com | |
"ROR" |
https://ror.org/05mw5ed57 |
Funders
Funder type
Industry
Study monitor provided by Gambro Corporate Research; financial support to participating clinics in relation to patient enrollment came from Gambro Svenska Försäljnings AB
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No |
