Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/12/2005
Date assigned
26/01/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16564941

Publication citations

  1. 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.

Additional files

Editorial Notes