Biomarker for Peritoneal Ultrafiltration Failure
Recruitment status was Recruiting
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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 |
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) |
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 |
Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital, Sun Yat-Sen University
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| 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 |
| 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. | |
| 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 June 18, 2013