Southampton Clinical Trials Unit

OCTOPuS Trial

Trial Overview

Trial Team

Sites

Presentations and Publications

Essential Trial Documentation

Title

Optimising Cardiac Surgery ouTcOmes in People with diabetes (OCTOPuS)

Trial Status

Open to recruitment

Description

There are currently two important uncertainties in the management of people with sub-optimally controlled diabetes undergoing intermediate and major surgery:

How to improve diabetes management in the weeks leading up to an elective procedure
Whether that improved management is reflected in improved outcomes post-surgery

We have previously assessed the feasibility of the OCTOPuS intervention, an outpatient intervention delivered to people with sub-optimally controlled diabetes before elective cardiac surgery.

The present study will assess whether this intervention can reduce HbA1c levels and improve post-surgery clinical outcomes.

Objectives

The primary objective is to investigate whether an outpatient intervention, delivered in the weeks prior to elective major cardiac surgery, can improve outcomes for people whose diabetes is sub-optimally controlled.

Trial Design

A multicentre, parallel group, single-masked, individually randomised trial comparing time from surgery until clinically fit for discharge between the OCTOPuS intervention and usual care in adults with sub-optimally controlled diabetes undergoing elective surgery.

Population

Adults (≥18 years old) with sub-optimally controlled type 1 or type 2 diabetes (HbA1c >53 mmol/mol if aged 18-75 years or HbA1c >64 mmol/mol if aged >75 years) undergoing elective cardiac surgery, who are clinically able to wait at least 2 months for their surgery.

This trial is funded by a National Institute for Health and Care research Health Technology Assessment programme (project number 16/25/12)

Sponsor: University Hospital Southampton NHS Foundation Trust

Trial registration: ISRCTN10170306

Trial Team:

Senior Trial Manager:

Elizabeth Dixon

Trial Manager:

TBC

Clinical Data Coordinator:

Steph Harding

Statistician:

Kerensa Thorne

Contact information:

Email: [email protected]

SAE Reporting:

Email: [email protected]

Investigator Team:

Chief Investigator:

Professor Richard Holt

Co-Investigators:

Dr Andrew Cook - University of Southampton

Dr Mayank Patel - University Hospital Southampton NHS Foundation Trust

Dr Helen Partridge - Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Mr Philip Newland- Jones - University Hospital Southampton NHS Foundation Trust

Mr Suvitesh Luthra - University Hospital Southampton NHS Foundation Trust

Mr Kareem Salhiyyah - Farah Medical Campus, Amman, Jordan

Professor Joanne Lord - University of Southampton

Professor Katharine Barnard-Kelly - Bournemouth University

Dr Amy Whitehead - University of Southampton

Ms Michelle Light - University of Southampton

Mr John Niven - PPI contributor

Professor Sunil Ohri - University Hospital Southampton NHS Foundation Trust

Set-up in progress

University Hospital Southampton NHS Foundation Trust
University Hospital of Wales
Leeds Teaching Hospital NHS Trust
Hull University Teaching Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust

Richard IG Holt. Developing an intervention to optimise cardiac surgery outcomes in people with diabetes: the OCTOPuS pilot study. Oral Presentation at the 14th International Jordan Cardiac Society conference, September 2021, Amman, Jordan.

Holt RIG, Dritsakis G, Barnard-Kelly K et al. The Optimising Cardiac Surgery ouTcOmes in People with diabeteS (OCTOPuS) randomised controlled trial to evaluate an outpatient pre-cardiac surgery diabetes management intervention: a study protocol. BMJ Open 2021;11:e050919. doi: 10.1136/bmjopen-2021-050919

Luthra, S., Salhiyyah, K., Dritsakis, G., Thorne, K.I., Dixon, E., Ohri, S., Holt, R.I.G. on behalf of the OCTOPuS study group. Diabetes management during cardiac surgery in the UK: A survey. Diabet Med, 38: e14388 (2021). https://doi.org/10.1111/dme.14388

Holt, R.I.G., Barnard-Kelly, K., Dritsakis, G. et al. Developing an intervention to optimise the outcome of cardiac surgery in people with diabetes: the OCTOPuS pilot study. Pilot Feasibility Stud 7, 157 (2021). https://doi.org/10.1186/s40814-021-00887-z

OCTOPuS Trial

Trial Overview

Trial Team

Sites

Presentations and Publications

Essential Trial Documentation

Title

Trial Status

Description

Objectives

Trial Design

Population

Trial Team:

Senior Trial Manager:

Clinical Data Coordinator:

Contact information:

SAE Reporting:

Investigator Team:

Set-up in progress

Essential Trial Documentation

ISF Documents

Case Report Forms