Clinical significance of Malnutrition-Inflammation-Atherosclerosis Syndrome in the patients on maintenance hemodialysis

ISRCTN ISRCTN61950442
DOI https://doi.org/10.1186/ISRCTN61950442
Secondary identifying numbers 1/2005
Submission date
06/08/2007
Registration date
06/09/2007
Last edited
22/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sanjin Racki
Scientific

Department of Nephrology and Dialysis
T. Strizica 3
Rijeka
51000
Croatia

sanjin.racki@ri.t-com.hr

Study information

Study designSingle-center, randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleClinical significance of Malnutrition-Inflammation-Atherosclerosis Syndrome in the patients on maintenance hemodialysis
Study objectivesApplication 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(s)Approved by Medical School of the University of Rijeka in June 2005.
Health condition(s) or problem(s) studiedEnd-stage renal disease treated with hemodialysis.
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/06/2005
Completion date01/07/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants208
Total final enrolment168
Key inclusion criteriaEnd-stage renal diasese on maintenance hemodialysis lasting at least 3 months.
Key exclusion criteria1. Previously transplanted
2. Previously treated with peritoneal dialysis
3. History of active infection in the last 3 months
Date of first enrolment01/06/2005
Date of final enrolment01/07/2007

Locations

Countries of recruitment

  • Croatia

Study participating centre

Department of Nephrology and Dialysis
Rijeka
51000
Croatia

Sponsor information

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

Trg hrvatskih velikana 6
Zagreb
10000
Croatia

ROR logo https://ror.org/0507etz14

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2010 22/05/2019 Yes No

Editorial Notes

22/05/2019: Publication reference and total final enrolment added.

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