Pentraxin-3 in Chronic Renal Failure

This study has been completed.
Sponsor:
Information provided by:
Haseki Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01397773
First received: July 18, 2011
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.


Condition
Inflammation
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters

Resource links provided by NLM:


Further study details as provided by Haseki Training and Research Hospital:

Primary Outcome Measures:
  • Pentraxin-3 level [ Time Frame: Five months ] [ Designated as safety issue: No ]
    Pentraxin-3 level will be compared with other inflammatory markers.


Secondary Outcome Measures:
  • Carotis intima media thickness [ Time Frame: Five months ] [ Designated as safety issue: No ]
    Correlation of Pentraxin-3 and carotis intima media thickness


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 85
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis group
Patients on chronic hemodialysis program
Peritoneal dialysis group
Patients on chronic peritoneal dialysis program
Pre-dialysis group
Patients with chronic kidney disease stage-4
Control group
Healthy subjects

Detailed Description:

The investigators planned to involve four group of patients: Hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media thickness will be measured in the radiology clinic. Statistical analysis will be carried on by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be selected among those who are followed up in our clinic.

Criteria

Inclusion Criteria:

  • To give informed consent
  • Hemodialysis or peritoneal dialysis for more than 3 months
  • Creatinin clearance less than 30 ml/min for the pre-dialysis group

Exclusion Criteria:

  • Not to give informed concent
  • Active infection within the last 3 months
  • Known chronic inflammatory disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397773

Locations
Turkey
Haseki Training and Research Hospital
Istanbul, Turkey, 34390
Sponsors and Collaborators
Haseki Training and Research Hospital
  More Information

No publications provided

Responsible Party: Meltem Gursu, Haseki Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01397773     History of Changes
Other Study ID Numbers: PTX-HASEKI
Study First Received: July 18, 2011
Last Updated: July 19, 2011
Health Authority: Turkey: Haseki Training and Research Hospital Local Ethical Commitee

Keywords provided by Haseki Training and Research Hospital:
Hemodialysis
peritoneal dialysis
chronic kidney disease
inflammation
carotis intima media thickness

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014