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

ISRCTN	ISRCTN61950442
DOI	https://doi.org/10.1186/ISRCTN61950442
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	1/2005
Sponsor	Ministry of Science, Education and Sport of the Republic of Croatia
Funder	Croatian Ministry of Science, Education and Sport (project number 0062015)

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

Email	sanjin.racki@ri.t-com.hr

Study information

Primary study design	Interventional
Study design	Single-center, randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title	Clinical significance of Malnutrition-Inflammation-Atherosclerosis Syndrome in the patients on maintenance hemodialysis
Study objectives	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(s)	Approved by Medical School of the University of Rijeka in June 2005.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	208
Total final enrolment	168
Key inclusion criteria	End-stage renal diasese on maintenance hemodialysis lasting at least 3 months.
Key exclusion criteria	1. Previously transplanted 2. Previously treated with peritoneal dialysis 3. History of active infection in the last 3 months
Date of first enrolment	01/06/2005
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Croatia

Study participating centre

Department of Nephrology and Dialysis

Rijeka
51000
Croatia

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	01/06/2010	22/05/2019	Yes	No

Editorial Notes

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