A multicentre, parallel group, single-masked, individually randomised trial incorporating a pre-planned futility analysis comparing time from surgery until clinically fit for discharge in adults with poorly controlled type 1 or 2 diabetes undergoing elective cardiothoracic surgery between the OCTOPuS intervention and usual care

niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 426 人开始时间: 2018年6月7日最近更新: 2022年2月21日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34108175/ (added 11/06/2021) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34404479/ Pilot study results (added 19/08/2021)

•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

•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

发起方

niversity Hospital Southampton NHS Foundation Trust