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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01667146




Registration number
NCT01667146
Ethics application status
Date submitted
12/08/2012
Date registered
17/08/2012

Titles & IDs
Public title
Open Lung Ventilation in ARDS: The PHARLAP Trial
Scientific title
A Multi-centre Randomised Controlled Trial of an Open Lung Strategy Including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in Patients With Acute Respiratory Distress Syndrome.
Secondary ID [1] 0 0
ANZIC-RC/AD002 Version 8
Universal Trial Number (UTN)
Trial acronym
PHARLAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Distress Syndrome 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - PHARLAP mechanical ventilation strategy
Other interventions - Control group mechanical ventilation strategy

Experimental: PHARLAP ventilation group - PHARLAP mechanical ventilation strategy

Active comparator: Control group ventilation - Control group mechanical ventilation strategy


Other interventions: PHARLAP mechanical ventilation strategy
Pressure control ventilation to maintain tidal volume 4-6 ml/kg and plateau pressure = 30 cmH2O while tolerating respiratory acidosis if pH \> 7.15; daily staircase recruitment manoeuvre and individualised PEEP titration.

Other interventions: Control group mechanical ventilation strategy
Mechanical ventilation based on the ARDSnet protocol using volume control ventilation with tidal volume 6 ml/kg, plateau pressure = 30 cmH2O and FiO2/PEEP titration according to a FiO2/PEEP/oxygen saturation combination chart. This has been modified for Australian and New Zealand practice to allow pressure control and pressure support ventilation.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Ventilator Free Days at Day 28 Post Randomisation
Timepoint [1] 0 0
28 days post randomisation
Secondary outcome [1] 0 0
PaO2/FiO2 Ratio and Static Lung Compliance
Timepoint [1] 0 0
Up to day 28 post randomisation
Secondary outcome [2] 0 0
Baseline to Day 3 Change in IL-8 and IL-6 Concentrations in Broncho-alveolar Lavage and Plasma
Timepoint [2] 0 0
Day 3 post randomisation
Secondary outcome [3] 0 0
Number of Severe Hypotension Events
Timepoint [3] 0 0
Up to 28 days post randomisation
Secondary outcome [4] 0 0
Number of Participants With Barotrauma
Timepoint [4] 0 0
Up to 90 days post randomisation
Secondary outcome [5] 0 0
Use of Rescue Therapies for Severe Hypoxaemia - Inhaled Nitric Oxide, Inhaled Prostacyclin, Prone Positioning, High Frequency Oscillatory Ventilation and Extracorporeal Membrane Oxygenation (ECMO)
Timepoint [5] 0 0
Within hospital admission
Secondary outcome [6] 0 0
Mortality
Timepoint [6] 0 0
at day 28
Secondary outcome [7] 0 0
ICU Length of Stay
Timepoint [7] 0 0
From admission to ICU up to 6 months
Secondary outcome [8] 0 0
Incidence of Acute Kidney Injury (AKI)
Timepoint [8] 0 0
Within hospital admission
Secondary outcome [9] 0 0
Quality of Life Assessment
Timepoint [9] 0 0
6 months post randomisation
Secondary outcome [10] 0 0
Cost Effectiveness Analysis
Timepoint [10] 0 0
6 months post randomisation
Secondary outcome [11] 0 0
Hospital Length of Stay
Timepoint [11] 0 0
From admission up to 6 months

Eligibility
Key inclusion criteria
Adult ICU patients who met all of the following criteria:

* Currently intubated and receiving mechanical ventilation
* Within 72 Hours of a diagnosis of ARDS (moderate and severe) based on the following Berlin definition:
* Within 1 week of a known clinical insult or new or worsening respiratory symptoms
* Bilateral opacities on chest x-ray (CXR) which are not fully explained by effusions, lobar/lung collapse or nodules
* Respiratory failure not fully explained by cardiac failure or fluid overload
* Arterial oxygen pressure (PaO2)/FiO2 < 200mmHg with PEEP = 5cmH2O
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* > 72 hours since diagnosis of ARDS
* > 10 days of continuous mechanical ventilation
* Barotrauma (pneumothorax, pneumomediastinum, subcutaneous emphysema or any intercostal catheter for the treatment of air leak)
* Significant chest trauma i.e. multiple rib fractures
* Active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma
* Clinical suspicion for significant restrictive lung disease (history of pulmonary fibrosis or suggestive pulmonary function tests)
* Moderate or severe traumatic brain injury, the presence of an intracranial pressure monitor, or any medical condition associated with a clinical suspicion of raised intracranial pressure
* Unstable cardiovascular status defined as sustained heart rate < 40 or > 140 bpm, ventricular tachycardia, or SBP < 80mmHg
* Pregnancy
* Receiving ECMO
* Receiving high frequency oscillatory ventilation
* Death is deemed imminent and inevitable
* The treating physician believes it is not in the best interest of the patient to be enrolled in the trial
* Consent not obtained or refused by patient's legal surrogate

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2018
Sample size
Target
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Albury/Wodonga - Albury
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Prince Alfred - Sydney
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [6] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [7] 0 0
Geelong Hospital - Geelong
Recruitment hospital [8] 0 0
The Alfred Hosptial - Melbourne
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Ireland
State/province [1] 0 0
Dublin
Country [2] 0 0
Ireland
State/province [2] 0 0
Limerick
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Saudi Arabia
State/province [4] 0 0
Riyadh
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Cambridgeshire
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Devon
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Kent
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Surrey
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Bristol
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Hull
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University College Dublin
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Carol Hodgson, PhD, FACP, BAppSc
Address 0 0
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
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)?
Yes
What data in particular will be shared?
The Australian and New Zealand Intensive Care Research Centre (ANZIC RC), Monash University supports the view that:

* Publicly funded research data should be made available with as few restrictions as possible
* Data sharing could enhance public well-being by maximising utilisation of gained knowledge, reducing redundant research and facilitating scientific innovation,
* Data sharing must be responsible, recognise legal, regulatory, ethical and commercial constraints.

The ANZIC-RC has formulated a policy and process to allow appropriate and responsible sharing of research data including prospective and completed studies.

This Policy was guided by, Institute of Medicine principles for responsible sharing of clinical trial data:

* Maximise the benefits of clinical trials
* Minimising the risks of data sharing
* Respect individual participants
* Increase public trust in clinical trials
* Conduct the sharing of trial data in a fair manner
* Appropriately manage conflicts of interest.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Is available on request
Available to whom?
request made to custodian via Australian and New Zealand Intensive Care Research Centre

See ANZIC-RC website term of reference document
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.monash.edu/medicine/sphpm/anzicrc/governance


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01667146