Oxygen concentration and myocardial stunning

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 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
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

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 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.