search
Back to results

The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure

Primary Purpose

End-Stage Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nocturnal vs conventional dialysis
Sponsored by
Rockefeller University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Dialysis, Cytokines, Triglycerides, Insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rockefeller University Hospital

Outcomes

Primary Outcome Measures

Feasibility study

Secondary Outcome Measures

Feasibility study

Full Information

First Posted
October 5, 2005
Last Updated
June 2, 2009
Sponsor
Rockefeller University
Collaborators
The Rogosin Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00234130
Brief Title
The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure
Official Title
A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
The patient population was not enough to complete enrollment
Study Start Date
July 2002 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rockefeller University
Collaborators
The Rogosin Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Dialysis, Cytokines, Triglycerides, Insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
nocturnal vs conventional dialysis
Primary Outcome Measure Information:
Title
Feasibility study
Secondary Outcome Measure Information:
Title
Feasibility study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa C. Hudgins, MD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure

We'll reach out to this number within 24 hrs