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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00438503
Other study ID # MED.RES.2007.02.EBP
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2007
Last updated September 14, 2015
Start date May 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 purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to analyse the relationship between the changes in blood pressure and changes in vasoactive hormones


Description:

The relationship between blood pressure during dialysis treatment and vasoactive hormones are studied. This includes measurements of plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin


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. Dialysis treatment for at least three month due to diabetic nephropathy

Exclusion Criteria:

1. Heart failure,

2. Lung insufficiency,

3. Chronic liver disease,

4. Malignant disease,

5. Nephrotic syndrome,

6. Lack of compliance,

7. Unwillingness to participate

Study Design

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


Intervention

Procedure:
Procedure


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 og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma
Secondary Relationship between changes in blood pressure and and changes in hormones
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