Additional identifiers
EudraCT number
2007-004012-31
ClinicalTrials.gov number
Protocol/serial number
RD 5130-009-07
Study information
Scientific title
The effects of improving oxygen concentration in the reduction of dialysis induced myocardial stunning - a pilot study
Acronym
Study hypothesis
Increasing oxygen concentration by administering inhaled oxygen reduces the severity and frequency of haemodialysis induced myocardial stunning.
Ethics approval
Trent Research Ethics Committee, 06/07/2009, ref: 09/H0405/18
Study design
Randomised controlled cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dialysis-induced myocardial stunning
Intervention
4 litres oxygen delivered by nasal cannulae during standard 4-hour haemodialysis.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Myocardial stunning
2. Development of regional wall motion abnormalities
Key observations are taken pre-dialysis (baseline) and 15 minutes prior to end of dialysis (peak stress) by cardiac echocardiography (for later offline semi-automated analysis for regional wall motion abnormalities).
Secondary outcome measures
Intradialytic haemodynamics; haemodynamic variables observed pre-dialysis, and throughout dialysis treatment, with continuous non-invasive measurement by finometer, and NICOM (bioreactance).
Overall trial start date
01/06/2010
Overall trial end date
01/11/2010
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
1. Male and female
2. Over 18 years old
3. Chronic haemodialysis greater than 4 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Cardiac transplant
2. New York Heart Association (NYHA) grade IV heart failure
3. Chronic obstructive airways disease, other chronic/acute lung condition exacerbating hypoxia and/or unable to tolerate O2 therapy
4. Patient on long-term oyxgen therapy (LTOT)
Recruitment start date
01/06/2010
Recruitment end date
01/11/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Derby Hospitals NHS Foundation Trust (UK)
Sponsor details
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 347141
teresa.grieve@derbyhospitals.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Kidney Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Basic results (scientific)
Publication list