NCT00218790

Brief Summary

A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

February 12, 2014

Status Verified

September 1, 2005

Enrollment Period

5 years

First QC Date

September 16, 2005

Last Update Submit

February 10, 2014

Conditions

End-stage Renal Disease

Keywords

SleepRenal failureDialysis

Outcome Measures

Primary Outcomes (1)

  • total sleep time

    amount of time slept per night

    9months

Secondary Outcomes (1)

  • quality of life

    9 months

Other Outcomes (1)

  • Comfort

    9 months

Study Arms (2)

Control group

NO INTERVENTION

The control group received standard dialysis at a temperature of 37 degrees Celcius

Experimental group

EXPERIMENTAL

Subjects in the experimental group received cool dialysate during treatment

Procedure: Cool Dialysate

Interventions

Cool DialysatePROCEDURE

Decreased temperature of the dialysis bath

Experimental group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.

You may not qualify if:

  • Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory affiliated hemodialysis units

Atlanta, Georgia, 30080, United States

Location

Emory University affiliated hemodialysis units

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

  • Parker KP, Bliwise DL, Bailey JL, Rye DB. Polysomnographic measures of nocturnal sleep in patients on chronic, intermittent daytime haemodialysis vs those with chronic kidney disease. Nephrol Dial Transplant. 2005 Jul;20(7):1422-8. doi: 10.1093/ndt/gfh816. Epub 2005 Apr 19.

    PMID: 15840682BACKGROUND

  • Lee KA, Landis C, Chasens ER, Dowling G, Merritt S, Parker KP, Redeker N, Richards KC, Rogers AE, Shaver JF, Umlauf MG, Weaver TE. Sleep and chronobiology: recommendations for nursing education. Nurs Outlook. 2004 May-Jun;52(3):126-33. doi: 10.1016/j.outlook.2003.12.002. No abstract available.

    PMID: 15197361BACKGROUND

  • Parker KP, Kutner NG, Bliwise DL, Bailey JL, Rye DB. Nocturnal sleep, daytime sleepiness, and quality of life in stable patients on hemodialysis. Health Qual Life Outcomes. 2003 Nov 21;1:68. doi: 10.1186/1477-7525-1-68.

    PMID: 14633280BACKGROUND

  • Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. doi: 10.1053/smrv.2001.0240.

    PMID: 12628214BACKGROUND

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kathy P. Parker, PhD,RN,FAAN

    Emory University, Nell Hodgson Woodruff School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

April 1, 2003

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 12, 2014

Record last verified: 2005-09

Locations

US(2)