Study of Peritoneal/Bowel Morphology and Splanchnic Hemodynamics by Sonography, Doppler Ultrasound and Computed Tomography in CAPD Patients - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00821405

Purpose

Use ultrasound and computed tomography to evaluate the condition of peritoneum(thickness, calcified, etc. )and correlate the relationship between the peritoneum and other clinical condition

Condition
Peritoneum Calcification Bowel Wall Calcification

MedlinePlus related topics: CT Scans Ultrasound

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

peritoneal thickness, calcification, PET, glucose loading [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
peritoneal dialysis peritoneal dialysis patient lasting for more than 3 months

Detailed Description:

The peritoneum after long-term peritoneal dialysis is inevitably associated with fibrosis, which further compromises the efficiency of dialysis and ultrafiltration, or even worse the development of encapsulating sclerosing peritonitis (EPS) and mortality. Transabdominal ultrasonography and computed tomography has been reported in the diagnosis of EPS. Until now, it remains a critical clinical issue to early diagnose thickening of peritoneum and preventing the formation of EPS. Transabdominal ultrasonography and computed tomography are convenient and non-invasive, and has been reported to detect the thickening of peritoneum in pediatric PD patients with a history of peritonitis.

Our recent published study confirmed the utility of transabdominal ultrasonography in the evaluation of parietal peritoneum in adult PD patients. In previous work, we examined and compared eighteen adult PD patients with PD duration of more than 7 years with other eighteen adult PD patients wit PD duration of less than 1 year. Our results indicated that sonographic thickness is associated with PD peritoneal transport characteristics but not with the duration of PD. This work was just published in Nephrology, Dialysis and Transplantation in year 2008. We believe that was the earliest published ultrasonographic study in adult PD patients.

This proposed study aims to extend from previous study by increasing examinee population to include all adult PD patients as a cross sectional observational study. We will utilize previously published sonographic examination method on PD patients (both B-mode and Doppler ultrasonography). We will collect the blood, urine and peritoneal effluent sample at the same time. We hope that through this large-scale survey we can elucidate more clearly the relationship between morphology and functional/transport characteristics of the parietal peritoneum during the natural course of renal replacement therapy with peritoneal dialysis. The results will form our basis of future longitudinal serial follow-ups for the adult PD patients. Besides, for those PD patients with suspected peritonitis, we will also perform non-invasive ultrasonographic examinations and collect relevant samples on the initial days of hospitalization in order to establish an "early predicting model" of severe, medical-refractory peritonitis by using transabdominal ultrasonography.

Peritoneum and bowel wall calcifications are found frequently in EPS, and although while pre-EPS stage. This study will utilize computed tomography to detect peritoneum and bowel calcifications in PD patients. We hope to found the relationship between calcification, peritoneum function, peritonitis frequency and future possibility of EPS.

Eligibility

Ages Eligible for Study:	15 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients received peritoenal dialysis more than 3 months

Criteria

Inclusion Criteria:

peritoneal dialysis more than 3 months

Exclusion Criteria:

1. pregnancy 2. received CT in recent 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821405

Contacts

Contact: Jenq-Wen Huang, MD

+886-2-23123456 ext 63288

007378@ntuh.gov.tw

Locations

Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

More Information

Responsible Party:	National Taiwan University Hospital ( Jenq-Wen Huang )
Study ID Numbers:	200808062R
Study First Received:	January 12, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00821405
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Number : 250~300 patients
Correlation between PET, glucose loading and peritoneal thickness/calcification

Study placed in the following topic categories:

Calcinosis
Metabolic Diseases
Metabolic disorder

Additional relevant MeSH terms:

Calcium Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009