The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure

This study has been terminated.
(The patient population was not enough to complete enrollment)
Sponsor:
Collaborator:
The Rogosin Institute
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00234130
First received: October 5, 2005
Last updated: June 2, 2009
Last verified: June 2009

October 5, 2005
June 2, 2009
July 2002
May 2006   (final data collection date for primary outcome measure)
Feasibility study
Same as current
Complete list of historical versions of study NCT00234130 on ClinicalTrials.gov Archive Site
Feasibility study
Same as current
Not Provided
Not Provided
 
The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure
A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure

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.

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 1:1). 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
End-Stage Renal Disease
Procedure: nocturnal vs conventional dialysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

Men and women at least age 18 who receive hemodialysis three times a week for at least 3 months and meet the criteria for home instruction in nocturnal dialysis -

Exclusion Criteria:

No diabetes, any unstable clinical condition, chronic infection (including hepatitis, HIV), endocrine disorders or serious digestive problems, lipid-lowering medication , LDL cholesterol <190 mg/dL and triglycerides less than 600 mg/dL, body mass index <35, blood pressure <160/100, hemoglobin >10.0, no cholesterol-lowering medicine, able to change from Renagel (has lipid effects) to Phoslo for the duration of the study, cigarette smoking no more than half a pack per day

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234130
RUH IRB # LHU 0486
No
Lisa Hudgins, MD, Rockefeller University
Rockefeller University
The Rogosin Institute
Principal Investigator: Lisa C. Hudgins, MD Rockefeller University
Rockefeller University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP