Condition category
Circulatory System
Date applied
13/11/2016
Date assigned
16/11/2016
Last edited
09/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. When the kidneys fail, they stop cleaning the blood, leading to the build-up of harmful waste products. Dialysis is a common treatment for kidney disease, where harmful waste products and excess fluid are removed from the body, usually by diverting a patient’s blood through a special filtering machine, which uses a solution called dialysate to draw waste products out of the blood to ‘clean’ it. Advanced glycation end products (AGE) are a family of waste products which are formed by reactions with sugar breakdown products (glucose metabolites). In patients undergoing dialysis treatment, AGE often accumulate, and build up in connective tissues, for example in the collagen of the skin. Some AGE are visible if UV light is shone on them through a device called an AGE-reader (skin autoflourescence). The aim of this study is to compare the skin autoflourescence in dialysis patients when a dialysate containing glucose and one containing no glucose is used.

Who can participate?
Adults who are on long term dialysis treatment at the dialysis unit at Norrlands University Hospital, Umeå, Sweden.

What does the study involve?
At the start of the study, participants have their skin autoflourescence measured using a special machine called an AGE reader This involves placing the forearm onto the machine which then shines light through the arm to measure the amount of light that is absorbed. The amount of AGE present in the skin can then be calculated. Participants then continue to receive dialysis using their usual glucose-containing dialysate for four weeks. Participants are then switched to a glucose-free dialysate. After the third and sixth dialysis session using the new dialysate (one and two weeks after the switch), the skin autoflourescence test is repeated.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involve with participating.

Where is the study run from?
Norrland University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
January 2007 to May 2009

Who is funding the study?
1. Västerbotten Läns Landsting (Sweden)
2. Norrlands Kidney Patient Association (Sweden)

Who is the main contact?
Professor Bernd Stegmayr
bernd.stegmayr@umu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernd Stegmayr

ORCID ID

http://orcid.org/0000-0003-2694-7035

Contact details

Norrland University Hospital
Universitetssjukhuset
Umeå
90185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Measuring skin- and plasmaautofluorescence in hemodialysis patients either with glucose free or glucose-containing dialysate

Acronym

Study hypothesis

The aim of this study is to investigate if the is a difference between the use of a dialysate not containing glucose compared with a glucose containing dialysate

Ethics approval

The Regional Ethical Review Board in Umeå. Dept. of Medical Research, 12/03/2008, ref: Dnr 08-023M

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Cardiovascular disease in hemodialysis patients

Intervention

Patients on chronic hemodialysis with glucose containing dialysis bath (contentration 5 mmol/L) continue their usual treatement for the initial four weeks of the study. Following this, the dialysis concentrate is switched to glucose free dialysate. The dialysis procedure does not differ by using a different dialysis concentrate.

At baseline and then one and two weeks after the dialysate switch (after the third and after the sixth dialysis treatment with glucose free dialysate), participants have their skin autofluorescence measured using anAGE Reader and their plasma autofluorescence measured uisng a Tecan Genios microplate reader.

Following the final measurement, the dialysate is changed back to the dialysate the participants were using prior to the study.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Skin autofluorescence is measured using the AGE Reader (DiagnOptics Technologies BV, Groningen, The Netherlands) at baseline, 1 and 2 weeks after dialysate is switched to glucose free dialysate.

Secondary outcome measures

Plasma autofluorescence is measured using a Tecan Genios microplate reader (Tecan Group Ltd., Männedorf, Switzerland) at baseline, 1 and 2 weeks after dialysate is switched to glucose free dialysate.

Overall trial start date

21/01/2007

Overall trial end date

11/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (age > 18 years), no upper limit of age
2. Chronic dialysis treatment (patients with dialysis treatment more than three months)
3. All patients treated at the dialysis unit at Norrlands university hospital, Umeå, Sweden, who give informed consent and have no exclusion criterias

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Ongoing infection (elevated CRP)
2. Inability to understand information and give informed consent
3. Patients with diabetes mellitus prone to hypoglycemia

Recruitment start date

31/03/2009

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Sweden

Trial participating centre

Norrland University Hospital
Universitetssjukhuset
Umeå
90185
Sweden

Sponsor information

Organisation

Norrlands University Hospital

Sponsor details

Dept. of Nephrology
Dialysis unit
Universitetssjukhuset
Umeå
90185
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Västerbotten Läns Landsting

Alternative name(s)

Västerbotten County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Norrlands Kidney Patient Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Bernd Stegmayr (bernd.stegmayr@umu.se) and Bernd Ramsauer (bernd.ramsauer@vgregion.se)

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28056864

Publication citations

Additional files

Editorial Notes

09/01/2017: Publication reference added.