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
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Feasibility study

Secondary Outcome Measures:
  • Feasibility study

Estimated Enrollment: 20
Study Start Date: July 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234130

Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
The Rogosin Institute
Investigators
Principal Investigator: Lisa C. Hudgins, MD Rockefeller University
  More Information

No publications provided

Responsible Party: Lisa Hudgins, MD, Rockefeller University
ClinicalTrials.gov Identifier: NCT00234130     History of Changes
Other Study ID Numbers: RUH IRB # LHU 0486
Study First Received: October 5, 2005
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockefeller University:
Dialysis
Cytokines
Triglycerides
Insulin

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014