Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234130
Status:
TERMINATED
Last Update Posted:
2009-06-03
First Post:
2005-10-05
Brief Title:
The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure
Status:
TERMINATED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The patient population was not enough to complete enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether a new form of home hemodialysis carried out at night during sleep reduces blood levels of hormone-like substances called cytokines that may cause fatigue and increase blood fats and sugar Participants will stay twice in the Rockefeller Hospital and receive a standard diet and blood testing Training for nocturnal hemodialysis will be provided at the nearby Manhattan Dialysis Center of The Rogosin Institute affiliated with The Rockefeller University
Detailed Description:
Patients treated with conventional hemodialysis for at least 3 months and interested in learning home nocturnal hemodialysis will be screened in the Rockefeller Outpatient Research Center If eligible during the first 8 day hospital stay participants will receive a standard diet and dialysis treatment nearby at the Rogosin Institute Dialysis Center During the last 2 days their blood will be frequently sampled for cytokines fats and sugar Dialysate will also be sampled They will have the same diet and tests repeated during a second admission after either 4 months of conventional dialysis or 1 month training for nocturnal dialysis followed by 3 months of home nocturnal dialysis randomized 11 After the second admission patients treated with conventional dialysis will be discharged from the study and trained in nocturnal hemodialysis Off-site computer monitoring will be utilized when patients dialyze themselves at home or during the admission in The Rockefeller University Hospital
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