Biomarker for Peritoneal Ultrafiltration Failure

Continuous Ambulatory Peritoneal Dialysis Clinical Trial

Official title:

Biomarker for Early Detection and Intervention of Peritoneal Ultrafiltration Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728806
• Other study ID #: SYSU-PROPDBM
• Status: Completed
• Phase: N/A
• First received: August 1, 2008
• Last updated: May 21, 2015
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal dialysis (PD) patients with different types of peritoneal solute transport by differential proteomics techniques.

This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.

Description:

Ultrafiltration failure (UFF) is an important cause of technical failure in PD patients. It may develop over time and is, therefore, especially important in longterm PD. However, the study on UFF is very limited so far, there are still lack of biomarker for early detection and intervention of UFF.

Proteomics uses a rapidly evolving group of technologies to identify, quantify, and characterize a global set of proteins. It is characterized by high-throughput, high specificity and high-sensitivity. Therefore, proteomics has become a major focus of recent medical research.

This study will examine the peritoneal tissue, serum and dialysate proteins of continuous ambulatory peritoneal dialysis (CAPD) patients with different types of peritoneal solute transport by differential proteomics techniques. Correlation analysis will be used for the relationship between clinical data and the differential proteins, as well as verification of the differential proteins in the peritoneal tissue, serum and dialysate of patients with UFF. This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Continuous ambulatory peritoneal dialysis patients whose primary disease is chronic glomerulonephritis, The range of age is 20 to 65 year old.

• serum albumin level = 35 g/L.

• Residual GFR = 2 ml/min/1.73 m2.

• 500 ml/d = urine output = 1000 ml/d.

• Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

• Patients who are secondary nephropathy.

• Patients with congestive heart failure, angina, myocardial infarction, severe valvular heart disease, malignant hypertension, hypertensive encephalopathy or cerebrovascular accident.

• Patients with chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Continuous Ambulatory Peritoneal Dialysis

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital, Sun Yet-sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China,