Development of Early Diagnostic Techniques and Setup of L... | NCT00912704

Studies
Development of Early Diagnostic Techniques and Setup of Local Therapeutic Guidelines and Standards

NCT00912704

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Jun 3, 2009Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 1998

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1998

Primary Completion Date

Mar 1998Actual

Completion Date

Dec 1998Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2009

Last Update Posted Date

Jun 3, 2009Estimated

Name	Class
Wake Forest University Health Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

End-stage renal disease (ESRD) is a healthy, social and economic threat worldwide. In the past ten years, the incidence and prevalence of ESRD patients have tremendously increased, ranking at the top in the world. The reasons for such high incidence and prevalence are multifactor. Early diagnosis and closed monitor of the patients with chronic kidney disease (CKD) may be beneficial, but not confirmed yet.The advising mechanisms for non-doing or withdraw long-term dialysis. All these studies will be performed in a multicentered project. Three medical centers in which CKD researches have been conducted for many years will provide a large cohort and share the data collected from their own hospitals. We expect that the results will provide an excellent guideline for CKD care, achieve cost-effectiveness of dialysis therapy and better life quality of ESRD patients.

Detailed Description

Purpose: Development of early diagnostic techniques and setup of local therapeutic guidelines and standards.

Design: The group plans to host the co-operation of hospitals, based on the geographical distribution of co-operation of several hospitals to choose the renal physician interviews the doctor and patient received a total of 30 objects was conducted qualitative in-depth interviews.

Time:2008/9/1~2011/8/31

Inclusion criteria): To withdraw from dialysis treatment of chronic kidney disease, qualitative research, to-depth interviews, field observation, video recording, and public hospitals at the same time the collection of literature.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic kidney disease patients with the end of dialysis to withdrawal.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not limited to the patient himself, as soon as the patient or family members decide to enter or removed after dialysis can be done by patients themselves or family members as well as the main decision-depth interviews with relevant medical and nursing staff.

Recently, a relative of reference are as follows:

Spouse.
Adult direct blood relatives of British Columbia.
Parents.
Brothers and sisters.
Grandparents.
Three pro-grandparents or extended family, such as blood.
Pro-marriage and so immediate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang Duan-Rong, doctor	the Institute of Health Care Organization Administration (IHCOA)	Principal Investigator

Locations

Not provided