The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure
| Tracking Information | |||||
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| First Received Date ICMJE | October 5, 2005 | ||||
| Last Updated Date | June 2, 2009 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility study | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00234130 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Feasibility study | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure | ||||
| Official Title ICMJE | A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure | ||||
| 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. |
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| 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 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | End-Stage Renal Disease | ||||
| Intervention ICMJE | Procedure: nocturnal vs conventional dialysis | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00234130 | ||||
| Other Study ID Numbers ICMJE | RUH IRB # LHU 0486 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lisa Hudgins, MD, Rockefeller University | ||||
| Study Sponsor ICMJE | Rockefeller University | ||||
| Collaborators ICMJE | The Rogosin Institute | ||||
| Investigators ICMJE |
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| Information Provided By | Rockefeller University | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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