Pentraxin-3 in Chronic Renal Failure

Inflammation Clinical Trial

Official title:

The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397773
• Other study ID #: PTX-HASEKI
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: July 19, 2011
• Start date: April 2010
• Est. completion date: January 2011

Study information

• Verified date: July 2011
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Haseki Training and Research Hospital Local Ethical Commitee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Inflammation
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pentraxin-3 level	Pentraxin-3 level will be compared with other inflammatory markers.	Five months	No
Secondary	Carotis intima media thickness	Correlation of Pentraxin-3 and carotis intima media thickness	Five months	No