- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00278057
STUDY OF GLUCOSE IN DIALYSIS WATER WITH REGARD TO BLOOD PRESSURE AND QUALITY OF LIFE
January 16, 2006 updated by: Regional Hospital Holstebro
PHASE 4 STUDY OT THE EFFECT OF GLUCOSE ADDED TO THE DIALYSIS FLUID ON BLOOD PRESSURE, BLOOD GLUCOSE AND QUALITY OF LIFE IN HEMODIALYSIS PATIENTS.
We wanted to test the hypotheses that blood pressure level was lower, that the variability of blood pressure and blood glucose was reduced, and that quality of life was improved when glucose was added to the dialysis fluid.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study was to determine the effect of glucose added to the dialysis fluid on 1.blood pressure and variation in blood pressure, 2.blood glucose and variation in blood glucose, and 3.quality of life in patients treated with chronic maintenance hemodialysis in a randomized, placebo-controlled, unblinded cross-over study.
Study Type
Interventional
Enrollment
55
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Holstebro, Denmark, 7500
- Department of Medicine, Holstebro Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age more than 18 years, both men and women, and hemodialysis treatment for more than three months
Exclusion Criteria:
- treatment with hemodiafiltration, change to another dialysis modality, renal transplantation, alcohol abuse defined as more than 21 drinks a week for men and more than 14 drinks a week for women, and unwillingness to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Erling B Pedersen, Professor, Holstebro Hospital, 7500 Holstebro, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Study Completion
May 1, 2003
Study Registration Dates
First Submitted
January 16, 2006
First Submitted That Met QC Criteria
January 16, 2006
First Posted (Estimate)
January 18, 2006
Study Record Updates
Last Update Posted (Estimate)
January 18, 2006
Last Update Submitted That Met QC Criteria
January 16, 2006
Last Verified
January 1, 2006
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MED. RES. HOS.2003.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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