Condition category
Urological and Genital Diseases
Date applied
06/08/2007
Date assigned
06/09/2007
Last edited
07/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sanjin Racki

ORCID ID

Contact details

Department of Nephrology and Dialysis
T. Strizica 3
Rijeka
51000
Croatia
sanjin.racki@ri.t-com.hr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1/2005

Study information

Scientific title

Acronym

Study hypothesis

Application of atorvastatin or Helixone® dialysis membrane or online hemodiafiltration would have beneficial effect on the morbidity and mortality of the patients with Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome on the maintenance hemodialysis.

Ethics approval

Approved by Medical School of the University of Rijeka in June 2005.

Study design

Single-center, randomised controlled trial.

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 treated with hemodialysis.

Intervention

Participants were randomised into 4 groups:
1. Current dialysis with atorvastatin (10 mg orally per day during the whole follow-up periode [24 months])
2. Dialysis using the Helixone® membrane
3. Online hemodiafiltration
4. Control group: current dialysis treatment only

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patient survival with or without MIA syndrome at 2 years
2. Survival of patient with MIA syndrome according to randomisation/intervention at 2 years

Secondary outcome measures

1. Determinantion of independent predictors of mortality in MIA syndrome patients at 2 years
2. Influence of intervention on laboratory parameters of MIA syndrome at 2 years
3. Safety assessement of atorvastatin application, checked after 1, 3, 6, 12 and 24 months according to known precautions for statin use
4. Hospitalisations rate and frequency of patients with or without MIA syndrome at 2 years

Overall trial start date

01/06/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

End-stage renal diasese on maintenance hemodialysis lasting at least 3 months.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

208

Participant exclusion criteria

1. Previously transplanted
2. Previously treated with peritoneal dialysis
3. History of active infection in the last 3 months

Recruitment start date

01/06/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Croatia

Trial participating centre

Department of Nephrology and Dialysis
Rijeka
51000
Croatia

Sponsor information

Organisation

Ministry of Science, Education and Sport of the Republic of Croatia

Sponsor details

Trg hrvatskih velikana 6
Zagreb
10000
Croatia

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Croatian Ministry of Science, Education and Sport (project number 0062015)

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

Publication citations

Additional files

Editorial Notes