Condition category
Urological and Genital Diseases
Date applied
26/11/2014
Date assigned
04/12/2014
Last edited
04/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many patients with end-stage renal (kidney)disease survive because of chronic dialysis. Dialysis does some of the work usually done by the kidneys, such as removing waste products and excess fluid, maintaining safe levels of potassium, sodium and bicarbonate in the blood stream and helping to control blood pressure. However dialysis patients have an increased risk of cardiovascular disease and therefore are at a high risk of premature death. This may be partly due to autonomic dysfunction, whereby the autonomic nervous system (which controls basic bodily functions such as heart rate, breathing rate, body temperature and so on) no longer works properly and chronic inflammation. We want to explore the effects of a non-invasive device 3-4 times weekly on inflammation in adult dialysis patients and potential changes in autonomic dysfunction over a period of 3 months.

Who can participate?
Adult patients undergoing chronic dialysis

What does the study involve?
Participants are treated with the Kinetic Oscillation Stimulation (KOS) device for 10-15 minutes, 3 times a week before their dialysis session. The device is inserted into a nostril with a probe which is then stimulated with a low electric current causing oscillations. The participant feels a vibrating sensation. We look for evidence of inflammation and assess variations in heart rate at the start and end of the study period.

What are the possible benefits and risks of participating?
Kinetic Oscillation Stimulation(KOS) is safe and has been used in over 100 patients with chronic rhinitis and migraine. The vibrating sensation is not painful but may cause a slight discomfort initially. If KOS does have an anti-inflammatory effect this may benefit the research subjects taking part in the study. However this cannot be guaranteed.

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

When is the study starting and how long is it expected to run for?
January 2014 to December 2016

Who is funding the study?
1. Stockholm County Council (ALF project) (Sweden)
2. Westman Foundation (Sweden)
3. Martin Rind Foundation (Sweden)

Who is the main contact?
Professor Annette Bruchfeld
Annette.bruchfled@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Professor Annette Bruchfeld

ORCID ID

Contact details

Dept of Renal Medicine
M99
Karolinska University Hospital
Stockholm
1186
Sweden
+46-8-58580000
annette.bruchfeld@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DIA-CAP version 1

Study information

Scientific title

Modulation of the Cholinergic Anti-inflammatory Pathway in DIAlysis

Acronym

DIA-CAP

Study hypothesis

The overall aim of this open-label study is to investigate the effect of a new, non-pharmacological method that may induce changes in autonomic dysfunction in the dialysis setting and thereby influence chronic inflammation

Ethics approval

Regional ethical review board, Stockholm, 23/04/2014, ref. 2014/538-31/1

Study design

Interventional, single-centre, open-label study.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic inflammation in chronic dialysis patients

Intervention

We will use the Kinetic Oscillation Stimulation (KOS) device in chronic hemodialysis 3 times weekly during 10-15 minutes prior to the dialysis session. The device is inserted into one of the nostrils with a probe which is then stimulated with a low electric current causing oscillations. The research subject experiences this as a vibrating sensation. Our hypothesis is that this may stimulate the cholinergic anti-inflammatory pathway via the vagus nerve and decrease inflammation in this patient group with underlying chronic inflammation.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Inflammatory markers in serum and in stimulated whole blood during follow-up compared to prior to stimulation.
2. Heart rate variability by EKG ( autonomic dysfunction assessment) during follow-up compared to prior to stimulation

Secondary outcome measures

Health assessment questionnaires

Overall trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All stable adult patients with no age limit undergoing chronic dialysis.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10-12

Participant exclusion criteria

Ongoing clinical infection.

Recruitment start date

24/11/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska University Hospital
Stockholm
Sweden

Sponsor information

Organisation

Karolinska University Hospital

Sponsor details

Dept of Renal Medicine
M99
Stockholm
14186
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Stockholms Läns Landsting

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Westman Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Martin Rind Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will as soon as possible present data from this study at conferences and as articles. However we are now in the early pilot stage and it is too early to present a time-line.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes