ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART)
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|ClinicalTrials.gov Identifier: NCT01374022|
Recruitment Status : Active, not recruiting
First Posted : June 15, 2011
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult||Other: ART Strategy Other: ARDSNet Strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1013 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS|
|Actual Study Start Date :||June 2011|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: ART Strategy
maximum alveolar recruitment plus PEEP titration
Other: ART Strategy
Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
Active Comparator: ARDSNet Strategy
standard strategy (ARDSNet)
Other: ARDSNet Strategy
Conventional mechanical ventilation strategy.
- Survival in 28 days [ Time Frame: 28 days ]Survival within 28 days from randomization
- Lenght of ICU stay [ Time Frame: Maximum 6-months ]Length of hospital stay from randomization to ICU discharge
- Lenght of hospital stay [ Time Frame: Maximum 6 months ]Length of hospital stay from randomization to hospital discharge
- Pneumothorax requiring drainage [ Time Frame: 7 days ]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.
- Barotrauma [ Time Frame: 7 days ]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.
- Days free of mechanical ventilation [ Time Frame: 28 days ]Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
- ICU survival [ Time Frame: Maximum 6-months ]Survival at ICU discharge.
- In-hospital survival [ Time Frame: Maximum 6-months ]Survival at hospital discharge.
- 6-month survival [ Time Frame: 6 months ]Survival within 6 months after randomization
- Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour; [ Time Frame: 1 hour ]Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour after randomization.
- Hypoxemia (PaO2 < 55mmHg) in the first hour [ Time Frame: 1 hour ]Hypoxemia (PaO2 < 55mmHg) in the first hour after randomization
- Severe acidosis (pH < 7.10) in the first hour [ Time Frame: 1 hour ]Severe acidosis (pH < 7.10) in the first hour after randomization
- Cardiorespiratory arrest within 24 hours [ Time Frame: 24 hours ]Cardiorespiratory arrest defined as unexpected cardiac arrest, not due to progressive refractory shock within 24 hours after randomization.
- Deaths with refractory hypoxemia within 7 days [ Time Frame: 7 days ]Death with refractory hypoxemia, defined as PaO2 < 55 mmHg in the last arterial blood gas analysis with FiO2 = 100%.
- Death with refractory acidosis within 7 days [ Time Frame: 7 days ]Death with refractory acidosis within 7 days, defined as pH ≤ 7.10 in the last arterial blood gas analysis
- Death with barotrauma within 7 days [ Time Frame: 7 days ]Death with barotrauma within 7 days after randomization. We consider as barotrauma any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele > 2cm detected on image exams, except those judged to be clearly caused by invasive procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374022
|Hospital do Coracao|
|Sao Paulo, SP, Brazil, 04005-000|
|Principal Investigator:||Alexandre B Cavalcanti, MD, PhD||Hospital do Coracao|
|Study Chair:||Carlos RR Carvalho, MD, PhD||Hospital do Coracao, Faculdade de Medicina da Universidade de Sao Paulo|