Condition category
Circulatory System
Date applied
28/09/2010
Date assigned
09/03/2012
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher McIntyre

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

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 measures

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

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

http://www.derbyhospitals.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes