The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure

End-Stage Renal Disease Clinical Trial

Official title:

A Comparison of the Effects of Conventional and Nocturnal Hemodialysis on the Inflammatory Response of Chronic Renal Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00234130
• Other study ID #: RUH IRB # LHU 0486
• Status: Terminated
• Phase: N/A
• First received: October 5, 2005
• Last updated: June 2, 2009
• Start date: July 2002
• Est. completion date: May 2006

Study information

• Verified date: June 2009
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• nocturnal vs conventional dialysis

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	The Rogosin Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility study
Secondary	Feasibility study

External Links

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