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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04878510




Registration number
NCT04878510
Ethics application status
Date submitted
25/04/2021
Date registered
7/05/2021

Titles & IDs
Public title
Non-invasive Ventilation and Dex in Critically Ill Adults
Scientific title
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Vanguard Pragmatic Randomized Controlled Trial (inDEX Trial)
Secondary ID [1] 0 0
13205
Universal Trial Number (UTN)
Trial acronym
inDEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Insufficiency 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dexmedetomidine
Other interventions - Placebo

Experimental: Dexmedetomidine Intervention - Patients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada. Guidelines, the infusion will start at a mid-range dose of 0.6mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (Richmond Agitation-Sedation Scale \[RASS\] = -2 to +1 or Riker Sedation-Agitation Scale \[SAS\] 3-4).

Placebo comparator: Control Intervention - Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 50mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans.


Treatment: Drugs: Dexmedetomidine
Dexmedetomidine is an a2-adrenergic agonist sedative commonly used in invasive mechanical ventilation that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to ?-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium.

Other interventions: Placebo
Normal saline placebo will be given as continuous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recruitment Rate
Timepoint [1] 0 0
At the completion of the trial (approximately 1 year).
Primary outcome [2] 0 0
Protocol Adherence; Proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention.
Timepoint [2] 0 0
At the completion of the trial (approximately 1 year).
Primary outcome [3] 0 0
Consent Rate
Timepoint [3] 0 0
At the completion of the trial (approximately 1 year).
Secondary outcome [1] 0 0
Acute care unit outcomes; Non-invasive ventilation (NIV) failure
Timepoint [1] 0 0
28 days post-randomization.
Secondary outcome [2] 0 0
Acute care unit outcomes; Acute Care Unite Length of Stay
Timepoint [2] 0 0
60 days post-randomization.
Secondary outcome [3] 0 0
Acute care unit outcomes; Duration of invasive mechanical ventilation
Timepoint [3] 0 0
60 days post-randomization.
Secondary outcome [4] 0 0
Acute care unit outcomes; Ventilation free Days
Timepoint [4] 0 0
28 days post-randomization.
Secondary outcome [5] 0 0
Process Outcomes; Number of patient-initiated device removal episodes.
Timepoint [5] 0 0
4 days post-randomization.
Secondary outcome [6] 0 0
Process Outcomes; Richmond-Agitation Sedation Scale (RASS) measurements
Timepoint [6] 0 0
4 days post-randomization.
Secondary outcome [7] 0 0
Process Outcomes; The mean NIV tolerance score.
Timepoint [7] 0 0
4 days post-randomization.
Secondary outcome [8] 0 0
Process Outcomes; Days spent with delirium
Timepoint [8] 0 0
28 days post-randomization.
Secondary outcome [9] 0 0
Process Outcomes; Cointerventions
Timepoint [9] 0 0
4 days post-randomization.
Secondary outcome [10] 0 0
Hospital Outcomes; Hospital length of stay
Timepoint [10] 0 0
60 days post-randomization.
Secondary outcome [11] 0 0
Hospital Outcomes; Mortality
Timepoint [11] 0 0
60 days post-randomization.
Secondary outcome [12] 0 0
Adverse Events: Bradycardia
Timepoint [12] 0 0
60 Days post-randomization
Secondary outcome [13] 0 0
Adverse Events: Severe bradycardia
Timepoint [13] 0 0
60 Days post-randomization
Secondary outcome [14] 0 0
Adverse Events: Clinically significant bradycardia
Timepoint [14] 0 0
60 Days post-randomization
Secondary outcome [15] 0 0
Adverse Events: hypotension
Timepoint [15] 0 0
60 Days post-randomization
Secondary outcome [16] 0 0
Adverse Events: clinically significant hypotension
Timepoint [16] 0 0
60 Days post-randomization
Secondary outcome [17] 0 0
Adverse Events: hypertension
Timepoint [17] 0 0
60 Days post-randomization
Secondary outcome [18] 0 0
Adverse Events: Cardiac Arrest
Timepoint [18] 0 0
60 Days post-randomization
Secondary outcome [19] 0 0
Functional Outcomes; quality of life
Timepoint [19] 0 0
60 Days post-randomization
Secondary outcome [20] 0 0
Functional Outcomes; clinical frailty
Timepoint [20] 0 0
60 Days post-randomization

Eligibility
Key inclusion criteria
1. Age =18 years
2. Patient receiving any NIV modality for acute respiratory failure of any etiology
3. Admitted to ICU, PACU, step-down unit (surgical or medical), or emergency department
4. Presence of one or more of the following after optimized NIV treatment

1. Agitation (Defined as a Richmond Agitation and Sedation Scale [RASS] score of =+2 or a Riker Sedation-Agitation Scale [SAS] score of =5)
2. Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia
3. Other reason that the physician feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Absence of a functioning pacemaker with one of the following: a-Persistent bradycardia defined as a heart rate (HR) =50bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome
2. Persistent hypotension, defined as a mean arterial pressure (MAP) =60mmHg despite volume resuscitation and vasopressors
3. Acute hepatic failure
4. Known allergy to dexmedetomidine
5. Pregnancy
6. Acute withdrawal from drugs or alcohol
7. Patients with post-extubation respiratory failure
8. Imminent need for endotracheal intubation
9. Death is deemed imminent and inevitable
10. Patient's goals of care do not include intubation and IMV
11. Patients already on dexmedetomidine at time of enrollment
12. Previously enrolled in the inDEX trial
13. Treating physician refuses enrollment (reasons for refusal will be captured)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/04/2024
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Saudi Arabia
State/province [2] 0 0
Riyadh

Funding & Sponsors
Primary sponsor type
Other
Name
St. Joseph's Healthcare Hamilton
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kimberley Lewis, MD
Address 0 0
Research Institute of St Joseph's Healthcare Hamilton
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04878510