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NCT00439023 Clinical Trial

Glucose in Dialysis Water in Non-diabetics

Renal Failure, Chronic Clinical Trial

Official title:
Effect of Glucose in Dialysis Water on Blood Pressure and Vasoactive Hormones in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00439023
Other study ID # MED.RES.2007.01.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: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The purposes are

1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and

2. to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other

Description:

Measurement of hormones and blood pressure during dialysis treatment.

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 months

Exclusion Criteria:

1. Heart failure,

2. Chronic liver disease,

3. Diabetes mellitus,

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

Related Conditions & MeSH terms

Intervention

Procedure:
• dialysis with glucose in dialysis water

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 glucose in dialysis water on blood pressure, insulin and vasoactive hormones one week
Secondary Relationship between changes in blood pressure and changes in hormones during treatment one week
See also
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Completed NCT01875523 - PK of Serelaxin in Severe Renal Impairment and ESRD Phase 1
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Terminated NCT00664066 - DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
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