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The University of Southampton
Southampton Clinical Trials Unit

OCTOPuS Trial

Title

 Optimising Cardiac Surgery ouTcOmes in People with diabetes

 Description

The two important uncertainties in the management of people with sub-optimally controlled diabetes undergoing surgery are i) how to improve diabetes management in the weeks leading up to an elective procedure, and ii) whether that improved management is reflected in improved outcomes post-surgery. This project will develop an outpatient intervention to be delivered to people with sub-optimally controlled diabetes in need of elective cardiac surgery.

 Objectives

The primary objective of the Intervention Development study is to produce a manualised intervention and associated training package, which is acceptable to patients and can be used in a multicentre randomised controlled trial involving at least 8 cardiothoracic centres across the UK.

If the intervention is acceptable to patients and healthcare professionals, we will then conduct a randomised controlled trial to assess whether the intervention can reduce their HbA1c, and improve clinical outcomes following cardiac surgery. The randomised controlled trial will be subject to a separate ethics submission.

Trial Design

A single centre, feasibility study to develop an outpatient manualised intervention and associated training package, which is acceptable to patients and healthcare professionals.

Trial Status

Open to recruitment

Population

Adults (18-75 yrs) with sub-optimally controlled type 1 or type 2 diabetes (HbA1c > 53 mmol/mol) undergoing elective cardiac surgery, who are clinically able to wait at least 3 months for their surgery.

Trial Team:

Senior Trial Manager:

Elizabeth Dixon (023 8120 5331)

Trial Manager:

Giorgos Dritsakis (023 8120 5588)

Clinical Data Coordinator:

Mike Radford (023 8120 3983)

Contact information:

Email: octopus@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting:

Email: ctu@soton.ac.uk

Fax: 0844 7740 621

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