The effect of early sedation with dexmedetomidine compared with placebo on 90-day mortality in older critically ill patients

Phase 4

Recruiting

• Conditions: Critically ill patients; Mechanical Ventilation; Sedation; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12620001088932
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

1.Age is equal to or older than 65 years
2.Intubated and receiving invasive mechanical ventilation in an intensive care unit
3.The treating clinicians believe that the patient will remain intubated and ventilated until the day after tomorrow (unlikely to be extubated next day)
4.The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.

Exclusion Criteria

1.Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours in an intensive care unit
2.Proven or suspected acute primary brain lesion such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury
3.Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness
4.Admission with a suspected or proven drug overdose or burns.
5.Administration of ongoing neuromuscular blockade
6.Mean arterial blood (MAP) pressure that is less than 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomization
7.Heart rate less than 55 beats per minute unless the patient is being treated with a betablocker or a high grade atrio-ventricular block in the absence of a functioning pacemaker
8.Known sensitivity to dexmedetomidine
9.Acute fulminant hepatic failure
10.Receiving full time residential nursing care
11.Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment
12.Patient has an underlying disease that makes survival to 90 days unlikely
13.Previously enrolled in the SPICE IV study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality will be collected through a phone follow-up by the sites research support staff. This is then entered into the study database.[90-days following randomization]

Secondary Outcome Measures

Name	Time	Method
A composite of Number of days alive and free of coma and delirium. This is collected through medical records and direct patient assessment for delirium, coma (RASS of < or = -4 unresponsive to voice or painful stimulus). [at 28 days following randomization ]; A composite score of Number of days alive and ventilator free collected directly from medical records and entered into study database.[at 28 days following randomization];Major Adverse Kidney Events (Mortality + Acute Kidney Injury > stage II, defined by Kidney Disease Improving Global Outcome (KDIGO) definition). This is collected directly from medical records and entered into study database.[at 28 days following randomization];Duration of mechanical ventilation in survivors This is collected directly from medical records and entered into study database.[ICU discharge ]; Hospital length of stay in survivors. This is collected directly from medical records and entered into study database.[Hospital discharge ]