ISRCTN ISRCTN23510813
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

Department of Renal Medicine
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study information

Study designRandomised controlled cross-over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effects of improving oxygen concentration in the reduction of dialysis induced myocardial stunning - a pilot study
Study objectivesIncreasing 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) studiedDialysis-induced myocardial stunning
Intervention4 litres oxygen delivered by nasal cannulae during standard 4-hour haemodialysis.
Intervention typeOther
Primary outcome measure1. 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 measuresIntradialytic haemodynamics; haemodynamic variables observed pre-dialysis, and throughout dialysis treatment, with continuous non-invasive measurement by finometer, and NICOM (bioreactance).
Overall study start date01/06/2010
Completion date01/11/2010
Reason abandoned (if study stopped)Lack of staff/facilities/resources

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24
Key inclusion criteria1. Male and female
2. Over 18 years old
3. Chronic haemodialysis greater than 4 months
Key exclusion criteria1. 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 enrolment01/06/2010
Date of final enrolment01/11/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Derby Hospital
Derby
DE22 3NE
United Kingdom

Sponsor information

Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom

Phone +44 (0)1332 347141
Email 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
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.