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

Hemodialysis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278057
• Other study ID #: MED. RES. HOS.2003.01
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2006
• Last updated: January 16, 2006
• Start date: May 2003
• Est. completion date: May 2003

Study information

• Verified date: January 2006
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Drug:
• dialysisis with and without glucose in the dialysis

Locations

Country	Name	City	State
Denmark	Department of Medicine, Holstebro Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark,