OCTOPuS
Research type
Research Study
Full title
Optimising Cardiac Surgery ouTcOmes in People with diabeteS
IRAS ID
239069
Contact name
Richard Holt
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation trust
ISRCTN Number
ISRCTN10170306
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
Diabetes is particularly common in people having heart surgery. People with uncontrolled diabetes tend to recover more slowly after surgery and have a higher risk of developing post-operative infections (both chest infections and in their surgical wounds). They cannot go home as quickly after surgery as those with well controlled diabetes and their risk of dying is higher.
A hospital team in Bournemouth has developed an outpatient based approach to improve diabetes management in the weeks before surgery. They have shown that this approach can reduced the length of stay in hospital in people receiving joint replacements. We will adapt this approach for use with people undergoing heart surgery.
We will initially test it to discover if patients find the intervention acceptable and feasible. We will also review the intervention with doctors and nurses, and change it as necessary.
We will then test then approach in approx. 15 hospitals in a randomised controlled trial, half the patients will receive the new intervention and half usual care.
After 100 patients in the study have had surgery we will test to see if the intervention has affected their diabetes control, by seeing if their average blood sugar levels have improved. If it has not, we will stop the trial, as it will be unlikely that the intervention works as hoped.
If the diabetes management has improved, we will invite a further 326 people with diabetes to take part. We will look to see if patients are ready to leave hospital earlier, and what effect it has had on infections and deaths. We will discuss patients’ experience of the intervention, to see if they think the effort involved in the intervention is worth it. We will also assess the cost of implementing this intervention.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0508
Date of REC Opinion
13 Nov 2018
REC opinion
Further Information Favourable Opinion