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| [ Print-friendly version ] |
| Scandinavian Prospective Randomised Outcome Study of Hemofiltration and Hemodialysis in Incident Dialysis Patients |
| ISRCTN | ISRCTN83264534 |
| ClinicalTrials.gov identifier | |
| Public title | Scandinavian Prospective Randomised Outcome Study of Hemofiltration and Hemodialysis in Incident Dialysis Patients |
| Scientific title | |
| Acronym | PROFIL |
| Serial number at source | N/A |
| Study hypothesis | 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 |
| Lay summary | |
| Ethics approval | Approved by the Karolinska Institute Ethics Review Board 29/12/1999, reference number: 99-292 |
| Study design | Prospective, randomised, controlled, parallel group design |
| Countries of recruitment | Denmark, Sweden |
| Disease/condition/study domain | End stage renal disease patients starting dialysis treatment |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 15/05/2000 |
| Anticipated end date | 28/02/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 48 |
| Interventions | Two different modes of dialysis, conventional hemodialysis (HD) versus hemofiltration (HF) |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | Study monitor provided by Gambro Corporate Research; financial support to participating clinics in relation to patient enrollment came from Gambro Svenska Försäljnings AB |
| Trial website | http://www.profilstudy.org |
| Publications | 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21252503 |
| Contact name | Prof Anders Alvestrand |
| Address |
Department of Clinical Science
Intervention and Technology Karolinska Institutet |
| City/town | Stockholm |
| Zip/Postcode | S 141 86 |
| Country | Sweden |
| Tel | +46 (0)858582656 |
| Fax | +46 (0)87114742 |
| anders.alvestrand@klinvet.ki.se | |
| Sponsor | Gambro Corporate Research (Sweden) |
| Address |
c/o Ingrid Ledebo
Gambro Corporate Research Box 10101 |
| City/town | Lund |
| Zip/Postcode | S-220 10 |
| Country | Sweden |
| Tel | +46 (0)46 16 91 76 |
| Fax | +46 (0)46 16 96 91 |
| ingrid.ledebo@gambro.com | |
| Date applied | 29/03/2006 |
| Last edited | 31/05/2011 |
| Date ISRCTN assigned | 27/04/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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