The effect of glucose added to dialysis fluid on blood pressure, blood glucose and quality of life in hemodialysis patients. A placebo controlled cross-over study

ISRCTN ISRCTN53978980
DOI https://doi.org/10.1186/ISRCTN53978980
Secondary identifying numbers 2003-01
Submission date
27/12/2005
Registration date
26/01/2006
Last edited
25/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Erling B Pedersen
Scientific

Department of Medical Research
Holstebro Hospital
Holstebro
7500
Denmark

Phone +45 (0)99125704
Email ebp@dadlnet.dk

Study information

Study designPlacebo-controlled unblinded cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study acronymBlood pressure and glucose in dialysis water
Study objectivesWe 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(s)Approved by the local medical ethics committee
Health condition(s) or problem(s) studiedChronic renal failure
InterventionGlucose 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 typeOther
Primary outcome measureBlood pressure, blood glucose, quality of life
Secondary outcome measuresBlood pressure variability, blood glucose variability
Overall study start date01/05/2003
Completion date31/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants55-60
Key inclusion criteriaAge more than 18 years, both men and women, and hemodialysis treatment for more than three months
Key exclusion criteria1. 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
Date of first enrolment01/05/2003
Date of final enrolment31/07/2004

Locations

Countries of recruitment

  • Denmark

Study participating centre

Department of Medical Research
Holstebro
7500
Denmark

Sponsor information

Holstebro Hospital (Denmark)
Hospital/treatment centre

Department of Medical Research
Holstebro Hospital
Holstebro
7500
Denmark

Phone +45 (0)99125704
Email ebp@dadlnet.dk

Funders

Funder type

Research organisation

Ringkjobing County (Denmark)

No information available

Danish Society of Nephrology (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2006 Yes No