Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004285
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
1999-10-18
Brief Title:
Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease
Status:
COMPLETED
Status Verified Date:
2017-09
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:
HEMO
Brief Summary:
OBJECTIVES I Evaluate whether hemodialysis providing a 2-pool variable volume urea kinetic modelling value of 105 versus 145 reduces mortality and morbidity in patients with end stage renal disease
II Compare the efficacy of high versus low flux dialyzer membranes
II Compare the efficacy of high versus low flux dialyzer membranes
Detailed Description:
PROTOCOL OUTLINE This is a randomized multicenter study Patients are stratified by center age and diabetes prior to dialysis initiation
Patients are randomly assigned to 1 of 4 groups moderate dose dialysis low flux membrane high dose dialysis low flux membrane moderate dose dialysis high flux membrane or high dose dialysis high flux membrane Moderate dose is a target eKtV of 105 and high dose is 145 The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea eKtV calculated with double pool kinetics
Patients are dialyzed 3 times a week in the shortest possible time minimum 25 hours adjusted for adequate fluid removal General medical care protein and calorie intake and dialyzer reuse and other aspects of dialysis therapy are standardized The protocol document lists approved dialyzers no unsubstituted cellulosic membranes are permitted
The intervention phase of this study is 5 years Patients are followed for survival
Patients are randomly assigned to 1 of 4 groups moderate dose dialysis low flux membrane high dose dialysis low flux membrane moderate dose dialysis high flux membrane or high dose dialysis high flux membrane Moderate dose is a target eKtV of 105 and high dose is 145 The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea eKtV calculated with double pool kinetics
Patients are dialyzed 3 times a week in the shortest possible time minimum 25 hours adjusted for adequate fluid removal General medical care protein and calorie intake and dialyzer reuse and other aspects of dialysis therapy are standardized The protocol document lists approved dialyzers no unsubstituted cellulosic membranes are permitted
The intervention phase of this study is 5 years Patients are followed for survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK046109 | NIH | None | None |
| U01DK046114 | NIH | None | None |
| U01DK046126 | NIH | None | None |
| U01DK046140 | NIH | None | None |
| U01DK046143 | NIH | None | None |
| U01DK049240 | NIH | None | None |
| U01DK049241 | NIH | None | None |
| U01DK049242 | NIH | None | None |
| U01DK049243 | NIH | None | None |
| U01DK049244 | NIH | None | None |
| U01DK049249 | NIH | None | None |
| U01DK049252 | NIH | None | None |
| U01DK049254 | NIH | None | None |
| U01DK049259 | NIH | None | None |
| U01DK049261 | NIH | None | None |
| U01DK049264 | NIH | None | None |
| U01DK049271 | NIH | None | httpsreporternihgovquickSearchU01DK049271 |