Clinical trial NCT00728806: Biomarker for Peritoneal Ultrafiltration Failure
Official title: Biomarker for Early Detection and Intervention of Peritoneal Ultrafiltration Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Ambulatory Peritoneal Dialysis
Keywords: Continuous Ambulatory Peritoneal Dialysis
Ultrafiltration failure
Biomarker
Proteomics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: