DExmedetomidine in Cardiac surgical Intraoperative Drug Evaluatio

Phase 3

• Conditions: Delirium; Surgery - Other surgery; Cardiovascular - Coronary heart disease; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12623001171606
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-13
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1.Adults undergoing cardiac surgery with cardiopulmonary bypass
2.Age 65 years and older
3.Sufficient English language to complete the cognitive testing in the opinion of the research team
4.Willing and able to comply with all study requirements, including treatment, timing, and assessments.

Exclusion Criteria

1.Dementia (pre-existing confirmed clinical diagnosis)
2.Known allergy to Dexmedetomidine (DEX)
3.Second or third-degree heart block
4.Heart rate less than 55 unless on concomitant beta blockade
5.Renal dialysis within 30 days of surgery
6.Life expectancy of less than 30 days regardless of surgery
7.Preoperative mechanical support other than intra-aortic balloon pump
8.Salvage surgery requiring cardiopulmonary resuscitation
9.Child-Pugh class C liver Cirrhosis
10.Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the study procedures.
11.Hearing loss, or medical or psychiatric condition that could preclude the ability of the patient to comply with study procedures.
12.Prior enrolment in DECIDE trial in prior 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days alive and free of delirium and coma in the first 14 days post-operatively [ Richmond Agitation Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU); for intubated patients) or 3D-CAM (3 minute confusion assessment method; for non-intubated patients). 14 days post-operative]

Secondary Outcome Measures

Name	Time	Method
umber of Days Alive and at Home in the first 30 days postoperatively [Hospital records and phone call follow-up 30 days post-operative ];Incidence of stage 2 or 3 acute kidney injury in the first 14 days postoperatively [Serum creatinine and urine output Daily for 14 days post-operative];Number of Ventilator-free days in first 14 days postoperatively[Ventilation status collected from medical records 14 days postoperative];Change in cognitive status[The Telephone Interview for Cognitive Status-modified (TICS-M) Days 30, 90 and 365 post-operative];Mortality [Hospital records 90 days postoperative]