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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00438295
Other study ID # MED.RES.2007.03.EBP
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2007
Last updated September 14, 2015
Start date August 2006
Est. completion date May 2007

Study information

Verified date September 2007
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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


Description:

To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age > 18 years,

2. both men and women,

3. chronic renal failure and dialysis treatment for at least three months

Exclusion Criteria:

1. Heart failure,

2. Lung insufficiency,

3. Chronic liver disease,

4. Diabetes mellitus,

5. Malignant disease,

6. Nephrotic syndrome,

7. Lack of compliance,

8. Unwillingness til participate

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
temperature control


Locations

Country Name City State
Denmark Holstebro Hospital Holstebro

Sponsors (1)

Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment
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