Contact information
Type
Scientific
Primary contact
Prof Erling B Pedersen
ORCID ID
Contact details
Department of Medical Research
Holstebro Hospital
Holstebro
7500
Denmark
+45 (0)99125704
ebp@dadlnet.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003-01
Study information
Scientific title
Acronym
Blood pressure and glucose in dialysis water
Study hypothesis
We wanted to test the hypotheses that blood pressure 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
Ethics approval
Approved by the local medical ethics committee
Study design
Placebo-controlled unblinded cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Chronic renal failure
Intervention
Glucose versus placebo
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
3. Quality of life in patients treated with chronic maintenance hemodialysis
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Blood pressure, blood glucose, quality of life
Secondary outcome measures
Blood pressure variability, blood glucose variability
Overall trial start date
01/05/2003
Overall trial end date
31/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Age more than 18 years, both men and women, and hemodialysis treatment for more than three months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
55-60
Participant exclusion criteria
1. Treatment with hemodiafiltration
2. Change to another dialysis modality
3. Renal transplantation
4. Alcohol abuse defined as more than 21 units a week for men and more than fourteen units a week for women
5. Unwillingness to participate
Recruitment start date
01/05/2003
Recruitment end date
31/07/2004
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Medical Research
Holstebro
7500
Denmark
Sponsor information
Organisation
Holstebro Hospital (Denmark)
Sponsor details
Department of Medical Research
Holstebro Hospital
Holstebro
7500
Denmark
+45 (0)99125704
ebp@dadlnet.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Ringkjobing County (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Danish Society of Nephrology (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16564941
Publication citations
-
Results
Sangill M, Pedersen EB, The effect of glucose added to the dialysis fluid on blood pressure, blood glucose, and quality of life in hemodialysis patients: a placebo-controlled crossover study., Am. J. Kidney Dis., 2006, 47, 4, 636-643, doi: 10.1053/j.ajkd.2006.01.007.