NCT00460863

Brief Summary

The purpose of this study is to test a novel application of an existing treatment - using col dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment) during hemodialysis for its ability to stabilize the sleep/wake cycle of patients receiving this chronic treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 24, 2014

Status Verified

May 1, 2008

Enrollment Period

4.7 years

First QC Date

April 16, 2007

Last Update Submit

April 22, 2014

Conditions

End Stage Renal Disease

Keywords

sleephemodialysisdaytime sleepinesstemperature

Outcome Measures

Primary Outcomes (3)

  • Polysomnographic measures of sleep

    At three time points over the nine month study period

  • Polysomnographic measures of daytime sleepiness

    At three time points over the nine month study period

  • Distal/proximal skin temperature gradient

    At three time points during the nine month study period

Secondary Outcomes (5)

  • Subjective measure of sleep quality

    Monthly during the nine month study period

  • Subjective measure of daytime sleepiness

    Monthly during the nine month study period

  • Subjective measure of mood

    Monthly during the nine month study period

  • Subjective measure of quality of life

    Monthly during the nine month study period

  • Subjective measure of functional health status

    Monthly during the nine month study period

Interventions

using cool versus warm dialysate during hemodialysisPROCEDURE

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 failures - diabetes, hypertension, glomerulonephritis, or polycystic kidney disease
  • Ability to read and write in English hemodialysis three times a week for at least 4 months
  • Clinically stable
  • KT/V \> 1.0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Kathy P Parker, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 17, 2007

Study Start

April 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 24, 2014

Record last verified: 2008-05

Locations

US(1)