Biomarker for Peritoneal Ultrafiltration Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00728806
First received: August 1, 2008
Last updated: May 21, 2015
Last verified: May 2015

August 1, 2008
May 21, 2015
October 2007
December 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00728806 on ClinicalTrials.gov Archive Site
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Biomarker for Peritoneal Ultrafiltration Failure
Biomarker for Early Detection and Intervention of Peritoneal Ultrafiltration Failure

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.

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.

Observational
Observational Model: Case Control
Not Provided
Retention:   Samples Without DNA
Description:

peritoneal tissue will be collected at the time of peritoneal dialysis catheter insertion or extubation. Serum and dialysate samples will be collected for protein analysis.

Non-Probability Sample

Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital, Sun Yat-Sen University

Continuous Ambulatory Peritoneal Dialysis
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00728806
SYSU-PROPDBM
Yes
Xue Qing Yu, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP