Dexmedetomidine and delirium in cardiac surgery

DECIDE study: Dexmedetomidine in Cardiac surgical Intraoperative Drug Evaluation

The DECIDE study is a large (n=1,100) four year, triple blind, placebo-controlled, randomised trial evaluating whether Dexmedetomidine (DEX) improves:

Days Alive and free of Delirium and Coma at 14 days
Days alive and at home at 30 days
1-year cognitive outcomes after cardiac surgery

The team is led by Professor Robert Sanders from the Department of Anaesthetics and the Institute of Academic Surgery, Royal Prince Alfred Hospital and will be run out of the National Health and Medical Research Council (NHMRC) Clinical Trials Centre.

The trial is funded by a $4.1 million grant from the NHMRC Clinical Trials and Cohort Studies scheme.

Please email Kirston Barton if you are at all interested in being involved, with your contact details and any questions.

Principal investigators

Professor Robert Sanders, University of Sydney (CIA)
Professor Meg Jardine
Professor Yahya Shehabi
Professor Paul Myles
Professor Sharon Naismith
Professor Paul Bannon
Professor Richard Lindley
Professor Gillian Heller
Dr Rashidul Mahumud
Ms Diana Trickett

Expression of Interest

Please email Kirston Barton if you are interested in being involved, or would like any further information about DECIDE.

Progress

The study team is finalising the study protocol and documents. It is anticipated the first patient will be recruited in early 2024.

Trial summary

Study summary
Delirium is a common complication of cardiac surgery that is distressing for patients, consumes health care resources, and is associated with cognitive decline and dementia. Promising data suggest that the α2-agonist dexmedetomidine (DEX) may reduce postoperative delirium. If proven, the impact of reducing delirium, hospital costs and protecting cognition through a short term, available intervention for a high-risk population is profound.

Dexmedetomidine in Cardiac surgical Intraoperative Drug Evaluation (DECIDE) is a triple blind, placebo-controlled, randomised trial (RCT) that will provide definitive, high-quality evidence on whether DEX reduces delirium, improves days alive and at home and preserves 1-year cognitive outcomes after heart surgery.

Eligibility
1100 adults aged >65 years old undergoing elective cardiac surgery with cardiopulmonary bypass.

Study intervention
Dexmedetomidine or matched placebo (Drawn up at 8 mcg/ml (or equivalent) in a volume of 100ml or 50ml) started at 0.7mcg/kg/h after induction of anaesthesia and before skin incision (BIS 40-60). Open label propofol commenced on transfer to ICU in accordance to study procedures.

Outcomes
Primary outcome
Days Free of Delirium or Coma and Alive, during first 14 days postoperative, defined according to standardised criteria using reliable validated instruments (conducted twice daily after cardiac surgery) and endorsed by our consumer engagement.

Key acute secondary outcome
Number of days alive and at home during the first 30 postoperative days.

Key intermediate secondary outcome
One-year cognitive decline, assessed using a validated instrument.

Health economic outcomes
Evaluation of cost-effectiveness will inform clinical guidelines and policy.

Sample size
1100 patients.

Study duration
Four years.

Funding

NHMRC Clinical Trials and Cohort Studies Grant: $A4,057,466.30

Operations Committee

Prof Rob Sanders
Ms Kirston Barton
Ms Besa Beqaj
Ms Paige Druce
Ms Claire Reynolds

Start up meeting

The start up meeting will be held at the 2024 CTN Strategic Research Workshop, Coogee NSW, 1-4 August.

Media releases

Delirium in older patients study awarded $4.1 million NHMRC grant - August 2023

Presentations

Presented at the CTN workshops in 2021 and 2023 by Professor Rob Sanders.