Acute Respiratory Distress SyndromePHARLAPNCT01667146

Open Lung Ventilation in ARDS: The PHARLAP Trial

A study testing PHARLAP mechanical ventilation strategy in people with Acute Respiratory Distress Syndrome, run by Australian and New Zealand Intensive Care Research Centre at 27 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Acute Respiratory Distress Syndrome
What is being tested?: PHARLAP mechanical ventilation strategy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 27 sitesin 5 countries
Study dates: Oct 2012to Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

> 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)

Show all 14Show fewer

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

Trial locations and contacts

27 sites in 5 countries.

Country

City, postcode or hospital

27 sites in 5 countries

United Kingdom10 sites

Southmead Hospital
Bristol
Royal Surrey County Hospital
Guildford, Surrey
Hull Royal Infirmary
Hull
King's College Hospital
London
North Middlesex University Hospital
London
University Hospital, Lewisham
London
James Cook University Hospital
Middlesbrough
Princess Royal University Hospital
Orpington, Kent
Peterborough City Hospital
Peterborough, Cambridgeshire
Derriford Hospital
Plymouth, Devon

Other trials in United Kingdom

Australia8 sites

Flinders Medical Centre
Adelaide, South Australia
Albury/Wodonga
Albury, New South Wales
The Prince Charles Hospital
Brisbane, Queensland
Geelong Hospital
Geelong, Victoria, 3220
Nepean Hospital
Kingswood, New South Wales, 2747
The Alfred Hosptial
Melbourne, Victoria, 3004
Royal Prince Alfred
Sydney, New South Wales
Wollongong Hospital
Wollongong, New South Wales, 2500

Other trials in Australia

Ireland5 sites

Adelaide and Meath (Tallaght) Hospital
Dublin
Beaumont Hospital
Dublin
Mater Misericordiae University Hospital
Dublin
St Vincents Hospital
Dublin
University Hospital Limerick
Limerick

Other trials in Ireland

New Zealand3 sites

Auckland City Hospital (DCCM)
Auckland, 1142
Auckland City Hospital CVICU
Auckland, 1142
Middlemore Hospital
Otahuhu, Auckland, 1640

Other trials in New Zealand

Saudi Arabia1 site

King Abdulaziz Medical City
Riyadh

Other trials in Saudi Arabia

About this study

Official 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.

Some people develop the condition called acute respiratory distress syndrome (ARDS). This is a condition where the lungs have become injured from one of a number of various causes, and do not work as they normally do to provide oxygen and remove carbon dioxide from the body. This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS are admitted to the intensive care unit (ICU) and need help with their breathing by being connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of the body causing other problems but also death.

Over the past few years, reducing the size of each breath delivered by the ventilator in conjunction with the use of an occasional sustained deep breath called a "recruitment manoeuvre" have been used to try to prevent further damage to the lungs in people with ARDS. This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research study to have some beneficial effects without causing any obvious harm, when compared to a current best practice ventilator strategy. The main beneficial effects of the PHARLAP strategy were to increase the amount of oxygen in the blood and to reduce markers of inflammation (the body reacting to a disease process) in the body. This study was too small to make a strong conclusion, so this study will be much larger and will assess whether patients who have developed ARDS are better off when we use the PHARLAP strategy. Three hundred and forty patients will be enrolled into this study in multiple ICUs across Australia and New Zealand.

The study hypothesis is that the PHARLAP strategy group will have a higher number of ventilator free days at day 28 than the control group.

Read the detailed description

340 adult patients who have developed ARDS within the last 72 hours (and within 10 days of commencing mechanical ventilation) will be enrolled in 25- 30 intensive care units (ICUs) and randomly allocated to either the PHARLAP or a control ventilation strategy. PHARLAP 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 Positive-end expiratory pressure (PEEP) titration.

Control strategy: Mechanical ventilation based on the ARDSnet protocol with tidal volume 6 ml/kg, plateau pressure ≤ 30 cmH2O and fraction inspired oxygen (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. A standardised weaning from mechanical ventilation guideline will be used in both groups

Conditions: Acute Respiratory Distress Syndrome
Being tested: PHARLAP mechanical ventilation strategy, Control group mechanical ventilation strategy
Medical subject headings: Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PHARLAP mechanical ventilation strategyOther
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.
Control group mechanical ventilation strategyOther
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.

Study groups in NCT01667146
Study group	Role	What they receive
PHARLAP ventilation group	Experimental	PHARLAP mechanical ventilation strategy Receives: Other: PHARLAP mechanical ventilation strategy
Control group ventilation	Active comparator	Control group mechanical ventilation strategy Receives: Other: Control group mechanical ventilation strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Ventilator Free Days at Day 28 Post Randomisation
This is the total number of days calculated from day 1 (randomisation) to day 28 on which the patient was alive and received no assistance from invasive mechanical ventilation. Scores range between 0 (no ventilator free days) to 28 (no days on ventilator).
Measured: 28 days post randomisation

Secondary outcomes (11)

PaO2/FiO2 Ratio and Static Lung Compliance
PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). ARDS severity Mild 200-300 / Moderate 100-200 / Severe <100.
Measured: Up to day 28 post randomisation
Baseline to Day 3 Change in IL-8 and IL-6 Concentrations in Broncho-alveolar Lavage and Plasma
IL-8 is an important protein related to inflammation, Interleukin (IL)-6 is produced at the site of inflammation and plays a key role in the acute phase response
Measured: Day 3 post randomisation
Number of Severe Hypotension Events
Hypotension requiring increased vasopressor Days 1-28
Measured: Up to 28 days post randomisation
Number of Participants With Barotrauma
Evidence of Pneumothorax requiring Drainage
Measured: Up to 90 days post randomisation
Use of Rescue Therapies for Severe Hypoxaemia - Inhaled Nitric Oxide, Inhaled Prostacyclin, Prone Positioning, High Frequency Oscillatory Ventilation and Extracorporeal Membrane Oxygenation (ECMO)
The use of various rescue therapies (each of the therapies is compared between groups - per patient). the various therapies measured are inhaled nitric oxide, inhaled prostacyclin, prone positioning, high frequency oscillatory ventilation and extracorporeal membrane oxygenation (ECMO)
Measured: Within hospital admission
Mortality
At timepoints: day 28
Measured: at day 28
ICU Length of Stay
The number of days a person stayed in the ICU. A fraction of a day is considered a day
Measured: From admission to ICU up to 6 months
Incidence of Acute Kidney Injury (AKI)
The incidence of Acute Renal Injury - measured by the use of Continuous Renal Replacement Therapy (CRRT) in each person
Measured: Within hospital admission
Quality of Life Assessment
SF36v2 will be used Medical Outcomes Study. Scoring the RAND is a two-step process. First, pre-coded numeric values are recoded. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
Measured: 6 months post randomisation
Cost Effectiveness Analysis
This will be based on EQ-5D. EQ-5D is the most widely used health-related quality of life questionnaire in health economic evaluations.[62] EQ-5D can be used to derive a set of values that reflect people's opinions of the relative importance of different health problems. These values can be used to derive QALYs for application in cost-effectiveness and cost-utility evaluations.
Measured: 6 months post randomisation
Hospital Length of Stay
The length of time in days a participant stayed in hospital. A fraction of a day is considered 1 day.
Measured: From admission up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Mar 2018

First posted17 Aug 2012 (estimated)
Study startOct 2012
Primary completionOct 2017
Study completionMar 2018

Why it stopped: Halted by the Management Committee after the publication of the ART Trial

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01667146
Sponsor's protocol ID: ANZIC-RC/AD002 Version 8
Acronym: PHARLAP
Status last verified: Feb 2024
First submitted: 12 Aug 2012
Last updated: 18 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Hodgson CL, Cooper DJ, Arabi Y, King V, Bersten A, Bihari S, Brickell K, Davies A, Fahey C, Fraser J, McGuinness S, Murray L, Parke R, Paul E, Tuxen D, Vallance S, Young M, Nichol A. Maximal Recruitment Open Lung Ventilation in Acute Respiratory Distress Syndrome (PHARLAP). A Phase II, Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 1;200(11):1363-1372. doi: 10.1164/rccm.201901-0109OC.
PubMed 31356105
Hodgson C, Cooper DJ, Arabi Y, Bennett V, Bersten A, Brickell K, Davies A, Fahey C, Fraser J, McGuinness S, Murray L, Parke R, Tuxen D, Vallance S, Young M, Nichol AD; PHARLAP Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP): a protocol for a phase 2 trial in patients with acute respiratory distress syndrome. Crit Care Resusc. 2018 Jun;20(2):139-149.
PubMed 29852853
Bihari S, Bersten A, Paul E, McGuinness S, Dixon D, Sinha P, Calfee CS, Nichol A, Hodgson C; PHARLAP Study Investigators. Acute respiratory distress syndrome phenotypes with distinct clinical outcomes in PHARLAP trial cohort. Crit Care Resusc. 2023 Oct 18;23(2):163-170. doi: 10.51893/2021.2.oa3. eCollection 2021 Jun.
PubMed 38045528
Wildi K, Bihari S, Bersten A, Dixon DL, Paul E, McGuinness S, Hodgson C, Nichol A, Chataway T, Colella AD, Gebhard CE, Chegeni N, Matigian N, LiBassi G, Passmore M, Bouquet M, Ritchie A, Suen J, Fraser J; PHARLAP Study Investigators. Early differential protein expression in blood and bronchoalveolar fluid among ARDS phenotypes. Sci Rep. 2026 Apr 22;16(1):18748. doi: 10.1038/s41598-026-43956-0.
PubMed 42020568

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT01667146
Acronym / sponsor ID: PHARLAP / ANZIC-RC/AD002 Version 8
Conditions: Acute Respiratory Distress Syndrome
Study type: Interventional
Recruitment status: TerminatedReason stopped: Halted by the Management Committee after the publication of the ART Trial
Enrolment: 115 participants (actual)
Lead sponsor: Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
Collaborators: University College Dublin
Study start: Oct 2012
Primary completion: Oct 2017 (actual)
Study completion: Mar 2018 (actual)
First posted: 17 Aug 2012 (estimated)
Results: Posted 18 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study hypothesis is that the PHARLAP strategy group will have a higher number of ventilator free days at day 28 than the control group.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PHARLAP ventilation group	Experimental	Other: PHARLAP mechanical ventilation strategyPHARLAP mechanical ventilation strategy
Control group ventilation	Active comparator	Other: Control group mechanical ventilation strategyControl group mechanical ventilation strategy

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (14 listed)

> 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PHARLAP mechanical ventilation strategyPressure 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	PHARLAP ventilation group
Control group mechanical ventilation strategyMechanical 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.	Other	Control group ventilation

Primary outcome

Number of Ventilator Free Days at Day 28 Post Randomisation
Time frame: 28 days post randomisation
This is the total number of days calculated from day 1 (randomisation) to day 28 on which the patient was alive and received no assistance from invasive mechanical ventilation. Scores range between 0 (no ventilator free days) to 28 (no days on ventilator).

11 secondary outcomes

PaO2/FiO2 Ratio and Static Lung Compliance
Time frame: Up to day 28 post randomisation
Baseline to Day 3 Change in IL-8 and IL-6 Concentrations in Broncho-alveolar Lavage and Plasma
Time frame: Day 3 post randomisation
Number of Severe Hypotension Events
Time frame: Up to 28 days post randomisation
Number of Participants With Barotrauma
Time frame: Up to 90 days post randomisation
Use of Rescue Therapies for Severe Hypoxaemia - Inhaled Nitric Oxide, Inhaled Prostacyclin, Prone Positioning, High Frequency Oscillatory Ventilation and Extracorporeal Membrane Oxygenation (ECMO)
Time frame: Within hospital admission
Mortality
Time frame: at day 28
ICU Length of Stay
Time frame: From admission to ICU up to 6 months
Incidence of Acute Kidney Injury (AKI)
Time frame: Within hospital admission
Quality of Life Assessment
Time frame: 6 months post randomisation
Cost Effectiveness Analysis
Time frame: 6 months post randomisation
Hospital Length of Stay
Time frame: From admission up to 6 months

Results and safety

Results posted to the registry on 18 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PHARLAP Ventilation Group	58	57
Control Group Ventilation	57	56

Primary outcome: Number of Ventilator Free Days at Day 28 Post Randomisation

Time frame: 28 days post randomisation. Median (Inter-Quartile Range). Unit: days

Measure	PHARLAP Ventilation Group n = 57	Control Group Ventilation n = 56
Value	16 (0 to 21)	14.5 (0 to 21.5)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events will be collected from randomisation up until the 90 day follow up, up to 90 days in total. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PHARLAP Ventilation Group	23 of 58 (39.7%)	9 of 58 (15.5%)	14 of 57
Control Group Ventilation	15 of 56 (26.8%)	4 of 56 (7.1%)	17 of 56

Limitations and caveats (from the sponsor): The power of the study was limited by lower than expected recruitment rates, early termination of the trial (due to the publication of the ART trial), and treatment crossovers. Blinding was not possible within the ICU, staff and relatives were aware of group allocation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31356105Hodgson CL, Cooper DJ, Arabi Y, King V, Bersten A, Bihari S, Brickell K, Davies A, Fahey C, Fraser J, McGuinness S, Murray L, Parke R, Paul E, Tuxen D, Vallance S, Young M, Nichol A. Maximal Recruitment Open Lung Ventilation in Acute Respiratory Distress Syndrome (PHARLAP). A Phase II, Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 1;200(11):1363-1372. doi: 10.1164/rccm.201901-0109OC.
Background: PubMed 29852853Hodgson C, Cooper DJ, Arabi Y, Bennett V, Bersten A, Brickell K, Davies A, Fahey C, Fraser J, McGuinness S, Murray L, Parke R, Tuxen D, Vallance S, Young M, Nichol AD; PHARLAP Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP): a protocol for a phase 2 trial in patients with acute respiratory distress syndrome. Crit Care Resusc. 2018 Jun;20(2):139-149.
Background: PubMed 38045528Bihari S, Bersten A, Paul E, McGuinness S, Dixon D, Sinha P, Calfee CS, Nichol A, Hodgson C; PHARLAP Study Investigators. Acute respiratory distress syndrome phenotypes with distinct clinical outcomes in PHARLAP trial cohort. Crit Care Resusc. 2023 Oct 18;23(2):163-170. doi: 10.51893/2021.2.oa3. eCollection 2021 Jun.
Derived from this study: PubMed 42020568Wildi K, Bihari S, Bersten A, Dixon DL, Paul E, McGuinness S, Hodgson C, Nichol A, Chataway T, Colella AD, Gebhard CE, Chegeni N, Matigian N, LiBassi G, Passmore M, Bouquet M, Ritchie A, Suen J, Fraser J; PHARLAP Study Investigators. Early differential protein expression in blood and bronchoalveolar fluid among ARDS phenotypes. Sci Rep. 2026 Apr 22;16(1):18748. doi: 10.1038/s41598-026-43956-0.
Individual participant dataSharing planned: Yes. 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.

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Not yet recruitingObservational study
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carol Hodgson, PhD, FACP, BAppSc study chair

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)

Alistair Nichol, PhD, FCICM study chair

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)

27 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United Kingdom, Australia, Ireland, New Zealand, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Ventilator Free Days at Day 28 Post Randomisation (time frame: 28 days post randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01667146, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.