SPICE IV
Research type
Research Study
Full title
Sedation Practice in Intensive Care Evaluation-SPICE IV. Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients. A Prospective, Multi-Centre, Double-Blind, Randomized, Controlled Trial
IRAS ID
1008709
Contact name
Matt Wise
Contact email
Sponsor organisation
Monash University
Eudract number
2022-501157-36
ISRCTN Number
ISRCTN37114000
Research summary
Patients who are critical ill in an intensive care unit (ICU) are often ventilated where a machine takes over their breathing. Patients who are ventilated can be given a strong medicine called a sedative to reduce anxiety and distress, and help them stay comfortable while they have a tube in their throat. There are different types of sedatives, and it is not clear which one is the best. Dexmedetomidine (DEX) is one type of sedative medicine.
Older patients undergoing ventilation in intensive care have an increased risk of dying and suffering complications such as delirium and renal failure than younger people. Previous research has indicated that patients aged 65 and older are more likely to survive when they are sedated using DEX.
This trial aims to investigate the effect of DEX to determine whether it improves how well older people do in ICU. Half of the patients will be given DEX and the other half will be given a placebo (which looks the same as DEX but does not have any active ingredient). As well as being given either dexmedetomidine or a placebo, patients will be given enough standard sedative drugs in order to achieve "light" sedation so that they feel comfortable.
Results will be compared between the two groups. We will find out whether DEX is better than placebo by measuring outcomes such as whether the patient lives, whether they experience delirium (which means they have confused thinking and a lack of awareness of their surroundings), how long they are ventilated for, and whether they experience injury to their kidneys. Patients will be able to participate in this trial if they are aged 65 or older and they require mechanical ventilation for more than 24 hours. This is a type of study called a randomised controlled trial.
Hospitals with intensive care units that treat these patients will be involved in this trial. The trial is set to start in 2024 in the United Kingdom and is anticipated to conclude by the end of 2026. Participants in the trial will be contacted for an assessment at 90 days and six months after enrolment to see how well they have recovered.REC name
Wales REC 3
REC reference
24/WA/0065
Date of REC Opinion
9 Apr 2024
REC opinion
Further Information Favourable Opinion