Contact information
Type
Scientific
Primary contact
Prof Anders Alvestrand
ORCID ID
Contact details
Department of Clinical Science
Intervention and Technology
Karolinska Institutet
Stockholm
S 141 86
Sweden
+46 (0)858582656
anders.alvestrand@klinvet.ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PROFIL
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
End stage renal disease patients starting dialysis treatment
Intervention
Two different modes of dialysis, conventional hemodialysis (HD) versus hemofiltration (HF)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/05/2000
Overall trial end date
28/02/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant 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
Recruitment start date
15/05/2000
Recruitment end date
28/02/2006
Locations
Countries of recruitment
Denmark, Sweden
Trial participating centre
Department of Clinical Science
Stockholm
S 141 86
Sweden
Sponsor information
Organisation
Gambro Corporate Research (Sweden)
Sponsor details
c/o Ingrid Ledebo
Gambro Corporate Research
Box 10101
Lund
S-220 10
Sweden
+46 (0)46 16 91 76
ingrid.ledebo@gambro.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Study monitor provided by Gambro Corporate Research; financial support to participating clinics in relation to patient enrollment came from Gambro Svenska Försäljnings AB
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21252503
Publication citations
-
Results
Alvestrand A, Ledebo I, Hagerman I, Wingren K, Mattsson E, Qureshi AR, Gutierrez A, Left ventricular hypertrophy in incident dialysis patients randomized to treatment with hemofiltration or hemodialysis: results from the ProFil study., Blood Purif., 2011, 32, 1, 21-29, doi: 10.1159/000323140.