Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients

Phase 1

• Conditions: Critically ill patients who are dependent on high level medical care including mechanical ventilation, vasopressors and sedative/analgesic medication; MedDRA version: 21.1Level: PTClassification code: 10014348Term: Elderly Class: 100000004869; MedDRA version: 21.1Level: LLTClassification code: 10067223Term: Invasive mechanical ventilation Class: 10042613; MedDRA version: 20.0Level: PTClassification code: 10077264Term: Critical illness Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2022-501157-36-00
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-11
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3100

Inclusion Criteria

Age = 65 years, The treating clinicians believe that the patient will remain intubated and ventilated until the day after tomorrow (i.e. unlikely to be extubated the following day), Intubated and receiving invasive mechanical ventilation in an intensive care unit, The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.

Exclusion Criteria

Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 18 hours in an intensive care unit, Receiving full time residential nursing care, Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment, Underlying disease that makes survival to 90 days unlikely, Previously enrolled in the SPICE IV study, Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury, Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness, Admission as a consequence of a suspected or proven drug overdose or burns, Administration of or need for ongoing neuromuscular blockade, A mean arterial blood (MAP) pressure that is less than 50 mmHg, despite adequate resuscitation and vasopressor support at time of randomization, Heart rate less than 55 beats per minute unless the patient is being treated with a beta-blocker, or a high grade atrio-ventricular block in the absence of a functioning pacemaker, Known sensitivity to dexmedetomidine, Acute fulminant hepatic failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate mortality among patients = 65 years of age given early DEX as a primary sedative agent to verify the findings of the sub-group analysis in SPICE III trial (Early sedation with dexmedetomidine vs usual care in critically ill patients).;Secondary Objective: 2. To compare other key clinical outcomes with early sedation with DEX compared with placebo in the age group = 65 years, 3. Explore possible mechanistic explanations for the observed effect in older patients in the SPICE III study.;Primary end point(s): The study primary outcome is 90-day all-cause mortality.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):•Number of days alive and free of coma and delirium at 28 days;Secondary end point(s):•Number of days alive and ventilator free at 28 days;Secondary end point(s):•Major Adverse Kidney Events at 28 days (Mortality + Acute Kidney Injury > stage II, defined by Kidney Disease Improving Global Outcome (KDIGO) definition;Secondary end point(s):•Duration of mechanical ventilation in survivors;Secondary end point(s):•Hospital length of stay in survivors