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| Sponsors and Collaborators: |
Rockefeller University The Rogosin Institute |
|---|---|
| Information provided by: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00234130 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
End-Stage Renal Disease |
Procedure: nocturnal vs conventional dialysis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Rockefeller University Hospital | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Lisa C. Hudgins, MD | Rockefeller University |
More Information
| Study ID Numbers: | RUH IRB # LHU 0486 |
| Study First Received: | October 5, 2005 |
| Last Updated: | January 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00234130 |
| Health Authority: | United States: Food and Drug Administration |
|
Dialysis Cytokines Triglycerides Insulin |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Insulin Inflammation Kidney Failure |
