Oxygen concentration and myocardial stunning
ISRCTN | ISRCTN23510813 |
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DOI | https://doi.org/10.1186/ISRCTN23510813 |
EudraCT/CTIS number | 2007-004012-31 |
Secondary identifying numbers | RD 5130-009-07 |
- Submission date
- 28/09/2010
- Registration date
- 09/03/2012
- Last edited
- 21/11/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christopher McIntyre
Scientific
Scientific
Department of Renal Medicine
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
Study design | Randomised controlled cross-over trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised cross over trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | The effects of improving oxygen concentration in the reduction of dialysis induced myocardial stunning - a pilot study |
Study objectives | Increasing oxygen concentration by administering inhaled oxygen reduces the severity and frequency of haemodialysis induced myocardial stunning. |
Ethics approval(s) | Trent Research Ethics Committee, 06/07/2009, ref: 09/H0405/18 |
Health condition(s) or problem(s) studied | Dialysis-induced myocardial stunning |
Intervention | 4 litres oxygen delivered by nasal cannulae during standard 4-hour haemodialysis. |
Intervention type | Other |
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 study start date | 01/06/2010 |
Completion date | 01/11/2010 |
Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 24 |
Key inclusion criteria | 1. Male and female 2. Over 18 years old 3. Chronic haemodialysis greater than 4 months |
Key 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) |
Date of first enrolment | 01/06/2010 |
Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
Phone | +44 (0)1332 347141 |
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teresa.grieve@derbyhospitals.nhs.uk | |
Website | http://www.derbyhospitals.nhs.uk/ |
Funders
Funder type
Charity
Kidney Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/11/2019: Added EudraCT number. EudraCT states that this trial was terminated on 15/08/2012 due to lack of staff and challenges with recruitment.