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STUDY OF GLUCOSE IN DIALYSIS WATER WITH REGARD TO BLOOD PRESSURE AND QUALITY OF LIFE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278057
First Posted: January 18, 2006
Last Update Posted: January 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
  Purpose
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.

Condition Intervention Phase
Hemodialysis Drug: dialysisis with and without glucose in the dialysis Phase 4

Study Type: Interventional
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Estimated Enrollment: 55
Study Start Date: May 2003
Estimated Study Completion Date: May 2003
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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278057


Locations
Denmark
Department of Medicine, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B Pedersen, Professor Holstebro Hospital, 7500 Holstebro, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00278057     History of Changes
Other Study ID Numbers: MED. RES. HOS.2003.01
First Submitted: January 16, 2006
First Posted: January 18, 2006
Last Update Posted: January 18, 2006
Last Verified: January 2006

Keywords provided by Regional Hospital Holstebro:
Blood pressure;
chronic renal failure;
diabetes mellitus;
dialysis fluid; glucose;
hemodialysis;
hypertension;
uremia.

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions