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Study on Early Sedation with Dexmedetomidine vs. Placebo for Older Critically Ill Patients on Ventilators

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of early sedation in older patients who are critically ill and require intensive medical care, including the use of machines to help them breathe, known as mechanical ventilation. The study involves patients who are 65 years or older and are in need of continuous sedative medication to ensure comfort and safety while receiving life-supporting treatments. The medication being tested is called Dexmedetomidine, which is given as a solution through an infusion. This trial compares the effects of Dexmedetomidine with a placebo, which is a substance with no active medication, to see if it can improve outcomes for these patients.

The main goal of the study is to evaluate the impact of using Dexmedetomidine as a primary sedative on the survival of patients over a period of 90 days. The study will also look at other important factors, such as the number of days patients are alive without experiencing coma or delirium, the number of days they are free from the ventilator, and any major kidney problems that may occur. Additionally, the study will assess how long patients need mechanical ventilation and their length of stay in the hospital.

The trial is expected to run until December 2025, with the recruitment of participants having started in August 2023. The findings from this study could help improve the care and treatment of older patients who are critically ill and require mechanical ventilation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to be 65 years or older and is currently receiving mechanical ventilation in an intensive care unit.

    The patient requires ongoing sedative medication for comfort and safety, and it is expected that the patient will remain intubated and ventilated until at least the day after tomorrow.

  2. Step 2

    Medication administration

    The patient receives either Dexmedetomidine or a placebo as a sedative. Dexmedetomidine is administered as a 100 micrograms/ml concentrate for solution via infusion.

    The placebo consists of 2 ml of saline, manufactured under the same conditions as Dexmedetomidine.

  3. Step 3

    Monitoring and evaluation

    The primary outcome of the study is to evaluate the 90-day all-cause mortality rate among patients.

    Secondary outcomes include the number of days alive and free of coma and delirium at 28 days, the number of days alive and ventilator-free at 28 days, and the occurrence of major adverse kidney events at 28 days.

  4. Step 4

    Duration of participation

    The study is estimated to conclude by December 1, 2025.

    The patient's participation involves ongoing monitoring and evaluation throughout the study period, with specific attention to the duration of mechanical ventilation and hospital length of stay in survivors.

Who can join the trial?

4 criteria

  • The patient must be **65 years of age or older**.
  • The doctors believe the patient will need to stay on a **breathing machine** until at least the day after tomorrow. This means the patient is not expected to be taken off the machine the next day.
  • The patient is currently **intubated** (a tube is placed in the airway to help with breathing) and is receiving help from a **mechanical ventilator** in an intensive care unit.
  • The patient needs to have **sedative medication** right away. This medication helps keep the patient comfortable and safe, and it also helps with the delivery of life support treatments.

Who cannot join the trial?

3 criteria

  • Patients who are critically ill and need a high level of medical care, such as machines to help them breathe (mechanical ventilation).
  • Patients who require medications to support their heart and blood pressure, known as vasopressors.
  • Patients who need medications to help them relax or relieve pain, referred to as sedative/analgesic medication.
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Investigated drugs

Dexmedetomidine is a medication used in this trial as a sedative for older patients who are critically ill and require ventilation. It is being tested to see if it can improve survival rates when used early as the main sedative. The trial aims to verify previous findings that suggested benefits of using dexmedetomidine in similar situations.

What is already known about the treatment

Dexmedetomidine – This medication is administered intravenously and is used primarily in hospital settings. It is currently being studied in clinical trials for its effectiveness as a sedative in critically ill patients, particularly those who are older and require mechanical ventilation. Dexmedetomidine works by activating certain receptors in the brain, which helps to calm the patient and reduce the need for other sedative medications. It is classified as a sedative and analgesic, and its use is being evaluated to determine its impact on mortality rates in older patients.

Investigated diseases

  • Acute Respiratory Distress Syndrome (ARDS)

    This condition occurs when fluid builds up in the tiny, elastic air sacs in the lungs, preventing them from filling with enough air. As a result, less oxygen reaches the bloodstream, depriving organs of the oxygen they need to function. ARDS typically develops in people who are already critically ill or have significant injuries. It progresses rapidly, often within a few hours to days after the initial injury or illness. Patients may experience severe shortness of breath, labored and unusually rapid breathing, and low blood pressure. Mechanical ventilation is often required to support breathing.

  • Acute Kidney Injury (AKI)

    This condition involves a sudden episode of kidney failure or damage that happens within a few hours or days. It causes a build-up of waste products in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The progression can lead to symptoms such as decreased urine output, swelling due to fluid retention, and fatigue. It is often seen in critically ill patients and can be reversible with appropriate care.

Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2022-501157-36-00Protocol codeV1.0Estimated enrolment3 260 patientsSponsorMonash University

sourced from the EU Clinical Trials Register and site verification

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