Temperature Control During Dialysis Treatment
Primary Purpose
Renal Failure, Chronic
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
temperature control
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure, Chronic focused on measuring glucose in dialysis water, dialysis treatment, temperature
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years,
- both men and women,
- chronic renal failure and dialysis treatment for at least three months
Exclusion Criteria:
- Heart failure,
- Lung insufficiency,
- Chronic liver disease,
- Diabetes mellitus,
- Malignant disease,
- Nephrotic syndrome,
- Lack of compliance,
- Unwillingness til participate
Sites / Locations
- Holstebro Hospital
Outcomes
Primary Outcome Measures
Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00438295
First Posted
February 20, 2007
Last Updated
September 14, 2015
Sponsor
Regional Hospital Holstebro
1. Study Identification
Unique Protocol Identification Number
NCT00438295
Brief Title
Temperature Control During Dialysis Treatment
Official Title
Effect of Temperature Control During Dialysis Treatment With Glucose in Dialysis Water in Patients With Chronic Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Regional Hospital Holstebro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control
Detailed Description
To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Chronic
Keywords
glucose in dialysis water, dialysis treatment, temperature
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
temperature control
Primary Outcome Measure Information:
Title
Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years,
both men and women,
chronic renal failure and dialysis treatment for at least three months
Exclusion Criteria:
Heart failure,
Lung insufficiency,
Chronic liver disease,
Diabetes mellitus,
Malignant disease,
Nephrotic syndrome,
Lack of compliance,
Unwillingness til participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling B Pedersen, Professor
Organizational Affiliation
Regional Hospital Holstebro
Official's Role
Study Chair
Facility Information:
Facility Name
Holstebro Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
12. IPD Sharing Statement
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Temperature Control During Dialysis Treatment
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