Scandinavian Prospective Randomised Outcome Study of Hemofiltration and Hemodialysis in Incident Dialysis Patients

ISRCTN	ISRCTN83264534
DOI	https://doi.org/10.1186/ISRCTN83264534
Protocol serial number	N/A
Sponsor	Gambro Corporate Research (Sweden)
Funder	Study monitor provided by Gambro Corporate Research; financial support to participating clinics in relation to patient enrollment came from Gambro Svenska Försäljnings AB

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

Department of Clinical Science
Intervention and Technology
Karolinska Institutet
Stockholm
S 141 86
Sweden

Phone	+46 (0)858582656
Email	anders.alvestrand@klinvet.ki.se

Study information

Primary study design	Interventional
Study design	Prospective, randomised, controlled, parallel group design
Secondary study design	Randomised controlled trial
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(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
Key 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
Completion date	28/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes