Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001766808
Ethics application status
Approved
Date submitted
29/11/2021
Date registered
23/12/2021
Date last updated
16/08/2022
Date data sharing statement initially provided
23/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does nebulised acetylcysteine improve oxygen delivery in intubated Intensive Care Unit patients?
Scientific title
A Randomised Control trial of standard care plus Nebulised Acetylcysteine vs standard care alone in invasively ventilated ICU patients with significant secretions burden
Secondary ID [1] 305900 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
NAC-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventilator Associated Pneumonia 324456 0
Invasive Ventilation 324458 0
Condition category
Condition code
Anaesthesiology 321944 321944 0 0
Other anaesthesiology
Respiratory 322114 322114 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nebulisation via ventilator circuit (or high flow circuit for tracheostomy patients) of 4ml of 20% acetylcysteine + 4ml of 0.9% NaCl until discontinuation of invasive respiratory support. Administration will be repeated every 6 hours for 48 hours
Adherence will be monitored by auditing drug charts
Intervention code [1] 322293 0
Treatment: Drugs
Comparator / control treatment
Standard care: Patients will receive warmed and humidified air via a ventilatory circuit incorporating a water bath. No routine nebulisations will be prescribed for the purposes of aiding clearance of respiratory secretions. Chest physiotherapy will continue to occur on an as needed basis, as dictated by clinical monitoring and imaging(there is no formalised guideline in our hospital for which patients shall receive physiotherapy, but will be assessed by medical, nursing and physiotherapy teams on a regular basis
Control group
Placebo

Outcomes
Primary outcome [1] 329701 0
Arterial partial pressure of oxygen vs Inhaled fraction of oxygen (PaO2/FiO2) ratio as assessed by arterial blood gas analysis
Timepoint [1] 329701 0
Arterial partial pressure of oxygen vs Inhaled fraction of oxygen (PaO2/FiO2) ratio as assessed by arterial blood gas analysis measured at 48 hours post enrolment
Secondary outcome [1] 403512 0
Mortality by accessing patient electronic medical record
Timepoint [1] 403512 0
Assessed at 90 days post-enrolment
Secondary outcome [2] 403513 0
Ventilator Free Days. Collected contemporaneously on study form.
Timepoint [2] 403513 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [3] 403514 0
Reintubation rates. Collected contemporaneously on study form.
Timepoint [3] 403514 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [4] 403515 0
Tracheostomy Rate Collected contemporaneously on study form.
Timepoint [4] 403515 0
From time of enrolment to 28 days post-enrolment,
Secondary outcome [5] 403516 0
Incidence of ventilator associated pneumonia
Collected contemporaneously on study form.
Timepoint [5] 403516 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [6] 403518 0
Incidence of therapeutic bronchoscopy
Collected contemporaneously on study form.
Timepoint [6] 403518 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [7] 403520 0
Incidence of bronchospasm, as diagnosed based on increase in Peak airway pressure and presence of wheeze on clinical examination
Timepoint [7] 403520 0
During invasive ventilation
Secondary outcome [8] 403522 0
Duration of vasopressor/inotrope utilisation (composite outcome) by accessing patient medication charts
Timepoint [8] 403522 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [9] 403523 0
Incidence of renal replacement therapy utilistation, Data collected by accessing patient electronic medical record
Timepoint [9] 403523 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [10] 403524 0
Positive End Expiratory Pressure (PEEP) values by reviewing ICU observation charts
Timepoint [10] 403524 0
At 24 hours (time of ABG analysis for primary outcome) after enrolment
Secondary outcome [11] 403525 0
Primary Ventilator Mode, as recorded hourly on ICU observation charts
Timepoint [11] 403525 0
The Ventilator mode which was used for the greatest duration over the first 24 hours after enrolment (time of ABG analysis for primary outcome)
Secondary outcome [12] 403526 0
Highest Peak airway pressures as documented in the ICU observation chart
Timepoint [12] 403526 0
Over the first 24 hours after enrolment
Secondary outcome [13] 404159 0
Number of complete days requiring invasive ventilation, Collected contemporaneously on study document
Timepoint [13] 404159 0
Measured up to day 28 after enrolment
Secondary outcome [14] 404163 0
subjective secretion burden as recorded on ICU observation
Timepoint [14] 404163 0
During first 48 hours after study enrolment
Secondary outcome [15] 404164 0
Adverse events, e.g. bronchospasm.
Collected contemporaneously on study document
Timepoint [15] 404164 0
During period of invasive ventilation, starting from study enrolment
Secondary outcome [16] 404165 0
Duration of hospital stay, from accessing electronic medical record
Timepoint [16] 404165 0
Assessed up to day 90 post study enrolment
Secondary outcome [17] 404166 0
Duration of ICU stay, collected from computerised medical records
Timepoint [17] 404166 0
Assessed up to 90 days post study recruitment
Secondary outcome [18] 404542 0
Subgroup analysis of patients of PaO2/FiO2 (as assessed by arterial blood gas analysis)
in patients with primary ICU admission diagnosis of respiratory sepsis/lower respiratory tract infection/pneumonia
Timepoint [18] 404542 0
24 hours post enrolment
Secondary outcome [19] 404543 0
Pre-specified subgroup analysis of patients with primary ICU admission diagnosis of respiratory sepsis/lower respiratory tract infection/pneumonia:
Ventilator Free Days. Collected contemporaneously on study form.
Timepoint [19] 404543 0
From time of enrolment to 28 days post-enrolment
Secondary outcome [20] 404544 0
Pre-specified subgroup analysis of patients with primary ICU admission diagnosis of respiratory sepsis/lower respiratory tract infection/pneumonia:
Mortality by accessing patient electronic medical record
Timepoint [20] 404544 0
Assessed at 90 days post-enrolment
Secondary outcome [21] 412991 0
Arterial partial pressure of oxygen vs Inhaled fraction of oxygen (PaO2/FiO2) ratio as assessed by arterial blood gas analysis
Timepoint [21] 412991 0
measured at 24 hours post enrolment
Secondary outcome [22] 412992 0
Arterial partial pressure of oxygen vs Inhaled fraction of oxygen (PaO2/FiO2) ratio as assessed by arterial blood gas analysis
Timepoint [22] 412992 0
72 hours post enrolment, 24 hours post discontinuation

Eligibility
Key inclusion criteria
Receiving invasive ventilation and with moderate to high secretion burden
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Duration of invasive ventilation anticipated to be < 24 hours
Acute asthma exacerbation
Pregnancy
Known intolerance to study drug

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)
We plan to utilise sequentially numbered, opaque envelopes,

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential envelopes populated with the use of a randomisation table

The rationale being that as we are trying to minimise costs, given the lack of any funding, we do not have access to a web based service
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
We calculated that a sample size of 120 patients, (approx 60 per group) would give a power of 90% to detect a 20% change in Mean PaO2/FiO2 ratio between 2 groups, with Co-efficient of variation of 0.4.

The co-efficient of variation is based on a trial by Bilan et al, of 70 patients that demonstrated a Standard Deviation (SD). of 100 and mean difference(MD) of 250 in the Pa02/Fi02 ratio

An interim data analysis after 40 patients enrolled to examine assumptions about the SD and MD

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/08/2022
Actual
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 24356 0
New Zealand
State/province [1] 24356 0
Waikato

Funding & Sponsors
Funding source category [1] 310247 0
Hospital
Name [1] 310247 0
Waikato Hospital
Country [1] 310247 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Hospital
Address
Waikato Hospital
183 Pembroke Street
Hamilton
Waikato 3204
Country
New Zealand
Secondary sponsor category [1] 311372 0
None
Name [1] 311372 0
None
Address [1] 311372 0
None
Country [1] 311372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309925 0
HDEC: Central Health and Disability Ethics Committee
Ethics committee address [1] 309925 0
Ethics committee country [1] 309925 0
New Zealand
Date submitted for ethics approval [1] 309925 0
02/12/2021
Approval date [1] 309925 0
30/05/2022
Ethics approval number [1] 309925 0
2022 FULL 11695

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

Contacts
Principal investigator
Name 115858 0
Dr Simon Gordon
Address 115858 0
Intensive Care Unit
Waikato Hospital
183 Pembroke Street
Hamilton
Waikato 3204
Country 115858 0
New Zealand
Phone 115858 0
+6427242681
Fax 115858 0
Email 115858 0
simon.gordon@waikatodhb.health.nz
Contact person for public queries
Name 115859 0
Simon Gordon
Address 115859 0
Intensive Care Unit
Waikato Hospital
183 Pembroke Street
Hamilton
Waikato 3204
Country 115859 0
New Zealand
Phone 115859 0
+64272426816
Fax 115859 0
Email 115859 0
simon.gordon@waikatodhb.health.nz
Contact person for scientific queries
Name 115860 0
Simon Gordon
Address 115860 0
Intensive Care Unit
Waikato Hospital
183 Pembroke Street
Hamilton
Waikato 3204
Country 115860 0
New Zealand
Phone 115860 0
+6427242681
Fax 115860 0
Email 115860 0
simon.gordon@waikatodhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The raw data that will be available for sharing will include duration of ventilation, ventilator settings, PaO2/FiO2 ratios, subjective secretion burden, occurence of adverse events, mortality, length of hospital stay, length of ICU stay
When will data be available (start and end dates)?
Data will be available from after publication to 10 years post initial patient enrolment
Available to whom?
Ethics committee
Hospital staff and regulatory agencies
Researchers undertaking similar projects or meta-analysis
Available for what types of analyses?
for regulatory purposes, to achieve the aims in the approved research proposal, for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
simonpgordon92@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14268Study protocol  simon.gordon@waikatodhb.health.nz Will be available by contacting the PI directly
14269Informed consent form  simon.gordon@waikatodhb.health.nz Undergoing finalisation, will be uploaded soon
14270Statistical analysis plan  simon.gordon@waikatodhb.health.nz
14271Clinical study report  simon.gordon@waikatodhb.health.nz
14272Ethical approval  simon.gordon@waikatodhb.health.nz Will be uploaded when available



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.