Peridialysis Project: The Influence of Predialysis Factors on the Initial Course of Dialysis (Peridialysis)
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|ClinicalTrials.gov Identifier: NCT02488200|
Recruitment Status : Unknown
Verified February 2018 by James heaf, Herlev Hospital.
Recruitment status was: Recruiting
First Posted : July 2, 2015
Last Update Posted : February 26, 2018
The present study plans to delineate the clinical, biochemical, sociological and psychological factors. involved in dialysis preparation, and their impact on dialysis initiation (DI), modality choice and prognosis. In particular the following questions are to be answered.
- What factors influence unplanned DI?
- What factors influence choice of dialysis modality?
- What factors influence choice of dialysis access?
- Why do physicians start dialysis?
- What factors in the predialytic period and its immediate aftermath (the "peridialytic" period) influence prognosis?
|Condition or disease||Intervention/treatment|
|End Stage Renal Disease||Other: No intervention|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1400 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Peridialysis Project: The Influence of Predialysis Factors on the Initial Course of Dialysis|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
- Other: No intervention
- Proportion of patients who start planned dialysis initiation as defined by the protocol [ Time Frame: 1 year ]
The patient's first dialysis is planned if:
- His first hemodialysis uses an AV fistula
- His first hemodialysis uses a permanent catheter as the patient's permanent access
- His first peritoneal dialysis is >6 days after catheter placement.
The patient's first dialysis is unplanned if:
- His first hemodialysis uses a temporary catheter
- His first hemodialysis uses a permanent catheter as the patient's temporary access (i.e. a later AV fistula is planned.
- His first peritoneal dialysis is <7 days after catheter placement.
- Death [ Time Frame: 1 year ]Time to patient death
- Choice of dialysis modality [ Time Frame: 1 year ]Centre HD, Home HD, CAPD or APD
- Choice of dialysis access [ Time Frame: 1 year ]AVF, AVG, Temporary CVC, Tunneled CVC, or PD catheter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488200
|Contact: James G Heaf, MD DMScemail@example.com|
|Herlev, Denmark, 2730|
|Contact: James G Heaf, MD DMSc +4535125361 firstname.lastname@example.org|
|Principal Investigator:||James G Heaf, MD DMSc||Herlev Hospital|