Respiratory Distress Syndrome, AdultARTNCT01374022
ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial
A study testing ART Strategy and ARDSNet Strategy in people with Respiratory Distress Syndrome, Adult, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- ART Strategy and ARDSNet Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,013 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intubated, mechanically ventilated patients with diagnosis of moderate to severe ARDS less than 72 hours
Who cannot join
- age less than 18 years
- use of vasopressor drugs in increasing doses over the last 2 hours or mean arterial blood pressure less than 65mmHg
- presence of any contraindication to hypercapnia as intracranial hypertension or acute coronary syndrome
- pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele
- patient with no therapeutic perspective, candidates for palliative care exclusively
- patient previously randomized in the ART
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS
Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Mechanical ventilation is recognized to play an important role in treatment of patients with ARDS. However, mechanical ventilation itself has the potential to produce or worsen alveolar injury if inadequate strategies are chosen. Several studies compared different mechanical ventilation strategies in ARDS but the results remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a multicentric randomized controlled trial, with allocation concealment and intention to treat analysis to investigate if maximum alveolar recruitment maneuver in association to Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART strategy) is able to increase 28 days survival in patients with moderate to severe ARDS compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients considered to this trial are those in mechanical ventilation with diagnosis of moderate to severe ARDS less than 72hours. Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6 months.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- ART Strategy, ARDSNet Strategy
- Keywords
- Respiratory Distress Syndrome, Adult, Randomized Controlled Trial, Respiration, Artificial
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART StrategyOther
Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
ARDSNet StrategyOther
Conventional mechanical ventilation strategy.
| Study group | Role | What they receive |
|---|---|---|
| ART Strategy | Experimental | maximum alveolar recruitment plus PEEP titration Receives: Other: ART Strategy |
| ARDSNet Strategy | Active comparator | standard strategy (ARDSNet) Receives: Other: ARDSNet Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in 28 days
Survival within 28 days from randomization
Measured: 28 days
Secondary outcomes (8)
Lenght of ICU stay
Length of hospital stay from randomization to ICU discharge
Measured: Maximum 6-months
Lenght of hospital stay
Length of hospital stay from randomization to hospital discharge
Measured: Maximum 6 months
Pneumothorax requiring drainage
We consider as pneumothorax requiring chest tube within 7 days any case that is possibly due to barotrauma, that is, we do not consider cases judged to be clearly caused by invasive procedures such as central venous punction or thoracocentesis.
Measured: 7 days
Barotrauma
We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele > 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures.
Measured: 7 days
Days free of mechanical ventilation
Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
Measured: 28 days
ICU survival
Survival at ICU discharge.
Measured: Maximum 6-months
In-hospital survival
Survival at hospital discharge.
Measured: Maximum 6-months
6-month survival
Survival within 6 months after randomization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, PhD, Principal investigator, Hospital do CoracaoCarlos RR Carvalho, MD, PhD, Study chair, Hospital do Coracao, Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374022
- Sponsor's protocol ID
- CAAE - 0025.1.160.000-11
- Acronym
- ART
- Status last verified
- Sep 2020
- First submitted
- 13 Jun 2011
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zampieri FG, Costa EL, Iwashyna TJ, Carvalho CRR, Damiani LP, Taniguchi LU, Amato MBP, Cavalcanti AB; Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial Investigators. Heterogeneous effects of alveolar recruitment in acute respiratory distress syndrome: a machine learning reanalysis of the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial. Br J Anaesth. 2019 Jul;123(1):88-95. doi: 10.1016/j.bja.2019.02.026. Epub 2019 Apr 5.
PubMed 30961913Damiani LP, Berwanger O, Paisani D, Laranjeira LN, Suzumura EA, Amato MBP, Carvalho CRR, Cavalcanti AB. Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial. Rev Bras Ter Intensiva. 2017 Apr-Jun;29(2):142-153. doi: 10.5935/0103-507X.20170024.
PubMed 28977255Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
PubMed 28973363Morais CC, De Santis Santiago RR, Filho JR, Hirota AS, Pacce PH, Ferreira JC, Camargo ED, Amato MB, Costa EL. Monitoring of Pneumothorax Appearance with Electrical Impedance Tomography during Recruitment Maneuvers. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1070-1073. doi: 10.1164/rccm.201609-1780LE. No abstract available.
PubMed 28409685ART Investigators. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial. Trials. 2012 Aug 28;13:153. doi: 10.1186/1745-6215-13-153.
PubMed 22929542
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS
- ClinicalTrials.gov ID
- NCT01374022
- Acronym / sponsor ID
- ART / CAAE - 0025.1.160.000-11
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Respiratory Distress Syndrome, Adult, Randomized Controlled Trial, Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Mechanical ventilation is recognized to play an important role in treatment of patients with ARDS. However, mechanical ventilation itself has the potential to produce or worsen alveolar injury if inadequate strategies are chosen. Several studies compared different mechanical ventilation strategies in ARDS but the results remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a multicentric randomized controlled trial, with allocation concealment and intention to treat analysis to investigate if maximum alveolar recruitment maneuver in association to Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART strategy) is able to increase 28 days survival in patients with moderate to severe ARDS compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients considered to this trial are those in mechanical ventilation with diagnosis of moderate to severe ARDS less than 72hours. Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART Strategy | Experimental | Other: ART Strategymaximum alveolar recruitment plus PEEP titration |
| ARDSNet Strategy | Active comparator | Other: ARDSNet Strategystandard strategy (ARDSNet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- intubated, mechanically ventilated patients with diagnosis of moderate to severe ARDS less than 72 hours
Key exclusion criteria (6 listed)
- age less than 18 years
- use of vasopressor drugs in increasing doses over the last 2 hours or mean arterial blood pressure less than 65mmHg
- presence of any contraindication to hypercapnia as intracranial hypertension or acute coronary syndrome
- pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele
- patient with no therapeutic perspective, candidates for palliative care exclusively
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 |
|---|---|---|
| ART StrategyMaximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system. | Other | ART Strategy |
| ARDSNet StrategyConventional mechanical ventilation strategy. | Other | ARDSNet Strategy |
Primary outcome
Survival in 28 days
Time frame: 28 days
Survival within 28 days from randomization
8 secondary outcomes
Lenght of ICU stay
Time frame: Maximum 6-months
Lenght of hospital stay
Time frame: Maximum 6 months
Pneumothorax requiring drainage
Time frame: 7 days
Barotrauma
Time frame: 7 days
Days free of mechanical ventilation
Time frame: 28 days
ICU survival
Time frame: Maximum 6-months
In-hospital survival
Time frame: Maximum 6-months
6-month survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 30961913Zampieri FG, Costa EL, Iwashyna TJ, Carvalho CRR, Damiani LP, Taniguchi LU, Amato MBP, Cavalcanti AB; Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial Investigators. Heterogeneous effects of alveolar recruitment in acute respiratory distress syndrome: a machine learning reanalysis of the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial. Br J Anaesth. 2019 Jul;123(1):88-95. doi: 10.1016/j.bja.2019.02.026. Epub 2019 Apr 5.
- Derived from this study: PubMed 28977255Damiani LP, Berwanger O, Paisani D, Laranjeira LN, Suzumura EA, Amato MBP, Carvalho CRR, Cavalcanti AB. Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial. Rev Bras Ter Intensiva. 2017 Apr-Jun;29(2):142-153. doi: 10.5935/0103-507X.20170024.
- Derived from this study: PubMed 28973363Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
- Derived from this study: PubMed 28409685Morais CC, De Santis Santiago RR, Filho JR, Hirota AS, Pacce PH, Ferreira JC, Camargo ED, Amato MB, Costa EL. Monitoring of Pneumothorax Appearance with Electrical Impedance Tomography during Recruitment Maneuvers. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1070-1073. doi: 10.1164/rccm.201609-1780LE. No abstract available.
- Derived from this study: PubMed 22929542ART Investigators. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial. Trials. 2012 Aug 28;13:153. doi: 10.1186/1745-6215-13-153.
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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.
Alexandre B Cavalcanti, MD, PhD principal investigator
Hospital do Coracao
Carlos RR Carvalho, MD, PhD study chair
Hospital do Coracao, Faculdade de Medicina da Universidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART Strategy and ARDSNet Strategy in people with Respiratory Distress Syndrome, Adult, run by Hospital do Coracao at 1 site in Brazil.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival in 28 days (time frame: 28 days). 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 NCT01374022, which also lists 5 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 11 Sep 2020.