Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510549
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
2007-07-16
Brief Title:
Comparison of the Impact of Dialysis Treatment Type on Patient Survival
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
A Prospective Randomized Multicenter Open Label Interventional Pilot Study To Compare Mortality Morbidity and QOL in Hemodialysis Versus Peritoneal Dialysis Subjects
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As the influence of type of dialysis on survival of end stage renal disease ESRD patients remains unanswered the present study is designed randomized prospective multicenter interventional to assess clinical outcomes and compare mortality morbidity Quality of Life QOL and cost effectiveness between maintenance In-center Hemodialysis ICHD and Continuous Ambulatory Peritoneal dialysis CAPD These data will ultimately bring clarity on whether or not any difference in patient survival exists between the two modalities
In order to test the feasibility of patients willingness to be randomized to two different modality groups and retained in the randomized group a pilot study is planned before the conduct of a main study
This pilot study comprises of a 6 months study plus a 6 months observation if there is possibility to switch the patients into the main study
All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be recorded in each site Patients who provide written inform consent for collecting relevant information will be screened using certain inclusionexclusion criteria Eligible patients will undergo a standardized education regarding ESRD and treatment options Thereafter the patient will be required to provide a second inform consent allowing for randomization and entrance into the study Eligible patient will be randomized to either PD or HD treatment
The patients will be followed for a period of 6 months during which patients will be treated with PD or HD as prescribed at each site while meeting the dialysis adequacy and other indicators For the first 3 months monthly visits are required after which an every 3 months visit is planned
In this pilot study the main objective is to assess the willingness of ESRD patients to be randomized to either PD or HD treatment thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study
In order to test the feasibility of patients willingness to be randomized to two different modality groups and retained in the randomized group a pilot study is planned before the conduct of a main study
This pilot study comprises of a 6 months study plus a 6 months observation if there is possibility to switch the patients into the main study
All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be recorded in each site Patients who provide written inform consent for collecting relevant information will be screened using certain inclusionexclusion criteria Eligible patients will undergo a standardized education regarding ESRD and treatment options Thereafter the patient will be required to provide a second inform consent allowing for randomization and entrance into the study Eligible patient will be randomized to either PD or HD treatment
The patients will be followed for a period of 6 months during which patients will be treated with PD or HD as prescribed at each site while meeting the dialysis adequacy and other indicators For the first 3 months monthly visits are required after which an every 3 months visit is planned
In this pilot study the main objective is to assess the willingness of ESRD patients to be randomized to either PD or HD treatment thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study
Detailed Description:
refer to brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None