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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:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00278057
First received: January 16, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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:

Drug Information available for: Dextrose
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00278057     History of Changes
Other Study ID Numbers: MED. RES. HOS.2003.01
Study First Received: January 16, 2006
Last Updated: January 16, 2006
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013