Biomarker for Peritoneal Ultrafiltration Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00728806
First received: August 1, 2008
Last updated: October 7, 2010
Last verified: March 2009
  Purpose

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.


Condition
Continuous Ambulatory Peritoneal Dialysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Biomarker for Early Detection and Intervention of Peritoneal Ultrafiltration Failure

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  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: NCT00728806

Contacts
Contact: Xueqing Yu, M.D.& Ph.D. 8620-87766335 yuxq@mail.sysu.edu.cn
Contact: Haiping Mao, M.D.& Ph.D. 8620-87755766 ext 8143 haipingmao@126.com

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University Recruiting
GuangZhou, Guangdong, China, 510080
Contact: Xueqing Yu, M.D. & Ph.D.    8620-87766335    yuxq@mail.sysu.edu.cn   
Contact: Haiping Mao, M.D. & Ph.D.    8620-87755766 ext 8143    haipingmao@126.com   
Principal Investigator: Xueqing Yu, M.D.& Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Xueqing Yu, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00728806     History of Changes
Other Study ID Numbers: SYSU-PROPDBM
Study First Received: August 1, 2008
Last Updated: October 7, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Continuous Ambulatory Peritoneal Dialysis
Ultrafiltration failure
Biomarker
Proteomics

ClinicalTrials.gov processed this record on September 14, 2014