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 |
| Protocol serial number | 2003-01 |
| Sponsor | Holstebro Hospital (Denmark) |
| Funders | Ringkjobing County (Denmark), Danish Society of Nephrology (Denmark) |
- 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
Scientific
Department of Medical Research
Holstebro Hospital
Holstebro
7500
Denmark
| Phone | +45 (0)99125704 |
|---|---|
| ebp@dadlnet.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Placebo-controlled unblinded cross-over study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Blood pressure and glucose in dialysis water |
| Study objectives | 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(s) | Approved by the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Blood pressure, blood glucose, quality of life |
| Key secondary outcome measure(s) |
Blood pressure variability, blood glucose variability |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Age more than 18 years, both men and women, and hemodialysis treatment for more than three months |
| Key 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 |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Medical Research
Holstebro
7500
Denmark
7500
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
