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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
TCTR20140814001 |
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Date of registration:
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14/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized, controlled trial of early versus late initiation of peritoneal dialysis
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Scientific title:
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A randomized, controlled trial of early versus late initiation of peritoneal dialysis |
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Date of first enrolment:
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01/10/2014 |
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Target sample size:
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400 |
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20140814001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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somchai
yongsiri |
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Address:
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Faculty of Medicine, Burapha University
20131
Chonburi
Thailand |
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Telephone:
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66-81-0011018 |
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Email:
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syongsiri@yahoo.com |
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Affiliation:
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Burapha University |
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Name:
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raweewan
witoon |
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Address:
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Faculty of Medicine, Burapha University
20131
Chonburi
Thailand |
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Telephone:
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66-81-8176664 |
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Email:
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r_aumy@hotmail.com |
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Affiliation:
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Burapha University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 CKD stage 5 patients with GFR 9 ml min 1 73m2
2 age 20 years and willing to participate in this study
3 under optimal care by nephrologist at least 2 months before initiation of peritoneal dialysis
4 under NHSO National health security office Thailand coverage
Exclusion criteria: 1 planned living related kidney transplantation
2 cancer disease with expected survival time less than 3 years
3 patients with indication for emergency dialysis including uremia pulmonary edema dyspnea resistant hypertension significant acidemia hyperkalemia unresponse to medical treatment
Age minimum:
20 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ESRD
Peritoneal dialysis
glomerular filtration rate
initiation of dialysis
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end stage renal disease patients
ESRD
Peritoneal dialysis
glomerular filtration rate
initiation of dialysis
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Intervention(s)
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early dialysis,late dialysis
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initiation of peritoneal dialysis when GFR > 6 ml/min/1.73m2,initiation of peritoneal dialysis when GFR
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Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
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Primary Outcome(s)
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survival rate 3 years after initiation of dialysis survival rate
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Secondary Outcome(s)
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1. Disease complications 3 years after initiation of dialysis a. Myocardial infarction b. Cerebrovascular event c. Infection,2. Dialysis complications 2 years after initiation of dialysis a. PD-related Peritonitis, exit site infection/tunnel infection b. Non-infectious complication c. Em,3. Quality of life every 6 months assess by EQ-5D-5L,4. Hospitalization every 6 months time to first hospitalization, total admission day,5. Residual renal function every 6 months rate of decline,6. Technique survival every 6 months dialysis mode,7. Nutritional assessment every 6 months malnutrition inflammation score,8. Economic evaluation every 6 months direct and indirect cost
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Source(s) of Monetary Support
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National Research Council (NRC)
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
crec_thailand@hotmail.com
CREC Central Reserch Ethics Committee
02 579 0117 Ext.
crec_thailand@hotmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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30/09/2015 |
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URL:
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