People who require elective major cardiac surgery and who have poorly controlled diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
A manualised out-patient intervention to be delivered by a trained health professional to people with poorly controlled diabetes to improve cardiac surgical outcomes compared to treatment as usual.
P
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/03/2021: 1. Aged = 18 years old with type 1 diabetes or type 2 diabetes 2. Sub-optimally managed diabetes defined as an HbA1c >53 mmol/mol (7%) for those =75 years old and an HbA1c >64 mmol/mol (8%) for those >75 years old. The higher HbA1c criterion for older people is to minimise the risk of iatrogenic hypoglycaemia. This will be measured using a near patient test at the cardiothoracic surgery outpatient appointment where the decision to proceed to surgery is made 3. Awaiting elective open-heart cardiac surgery 4. Anticipated delay before surgery of at least 2 months 5. Surgery will take place at a hospital participating in the trial 6. Ability to give informed consent. 7. Ability to interact with the study documentation and processes. Previous inclusion criteria: 1. Adults (aged >18 years) with poorly controlled type 1 or type 2 diabetes. Poor control is defined as an HbA1c > 53 mmol/mol using a near-patient test at the cardiothoracic outpatients appointment where the decision to proceed to surgery is made 2. Awaiting elective cardiac surgery, where it is anticipated the delay before surgery will be at least 3 months (updated 13/02/2019 to ‘2 months’) 3. Ability to give informed consent 4. Ability to interact with the study documentation and processes
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 19/03/2021: 1. Active malignancy, where the malignancy is currently being treated by chemotherapy, surgery or radiotherapy or is likely to cause death within 6 months 2. Pregnancy 3. Previous cardiac surgery 4. Known haemoglobinopathies that affect the measurement of HbA1c 5. Other illnesses or conditions that would preclude engagement with the OCTOPuS intervention 6. Surgery taking place outside the participating hospitals, e.g. at a private hospital Previous exclusion criteria: 1. Malignancy (updated 13/02/2019 to ‘Active malignancy’) 2. Pregnancy 3. Previous cardiac surgery 4. Other illnesses or conditions that would preclude engagement with the OCTOPuS intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from surgery until clinically fit for discharge, as judged by the surgical team, measured using medical notes at 7 and 30 days post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/03/2021: 1. Time from surgery to actual discharge from hospital – this recognises that discharge can be delayed for non-clinical reasons 2. Days alive between surgery and either out of hospital or judged as clinically fit for discharge 3. Pre-operative mortality; 30-day mortality; 90-day mortality 4. Time on ITU 5. Time on a ventilator 6. Sternal Wound Infections, defined according to the NICE guidance and the CDC criteria 7. Leg wound infections, in those who provide donor veins; graded according to the Centers for Disease Control and Prevention definitions of surgical site infections 8. Chest infections, defined as a change in typical chest symptoms (cough, increased respiratory rate, shortness of breath) in conjunction with a fever or inflammatory markers 9. Urinary tract infections, defined as "clinically-diagnosed and treated, whether or not results from a urine culture are available" 10. Acute Coronary Syndrome 11. Change in weight between randomisation and surgery 12. Effect on postoperative renal function and incidence of acute kidney injury as assessed by measurement of serum creatinine and calculation of estimated glomerular filtration rates 13. HbA1c immediately preoperative, and at between 90 and 180 days post-operation 14. Change in HbA1c between baseline and immediately preoperative, and change from preoperative to between 90 and 180 days post-operation 15. Operations cancelled for sub-optimal glycaemic management 16. Frequency and severity of self-reported overall, minor, severe and nocturnal hypoglycaemia assessed at Baseline, during the Support Contact and Pre-surgery 17. EQ-5D at baseline, 7, 30 and 90 days post-surgery 18. Qualitative interviews and psychosocial questionnaires at baseline and 90 days post-surgery to explore participants’ experiences and perceived benefits of the intervention and any changes to their diabetes self-management. 19. Cost-effectiveness of the intervention, including: use of N | — |
Countries
England, United Kingdom
Contacts
Public ContactLiz;Giorgos Dixon;Dritsakis
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Outcome results
None listed