Clinical trial NCT01374022: ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial
Official title: Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Keywords: Respiratory Distress Syndrome, Adult
Randomized Controlled Trial
Respiration, Artificial
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* intubated, mechanically ventilated patients with diagnosis of moderate to severe ARDS less than 72 hours

Exclusion Criteria:

* 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

Primary outcomes:
measure: Survival in 28 days
timeFrame: 28 days
Secondary outcomes:
measure: Lenght of ICU stay
timeFrame: Maximum 6-months
measure: Lenght of hospital stay
timeFrame: Maximum 6 months
measure: Pneumothorax requiring drainage
timeFrame: 7 days
measure: Barotrauma
timeFrame: 7 days
measure: Days free of mechanical ventilation
timeFrame: 28 days
measure: ICU survival
timeFrame: Maximum 6-months
measure: In-hospital survival
timeFrame: Maximum 6-months
measure: 6-month survival
timeFrame: 6 months
Other outcomes:
measure: Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour;
timeFrame: 1 hour
measure: Hypoxemia (PaO2 < 55mmHg) in the first hour
timeFrame: 1 hour
measure: Severe acidosis (pH < 7.10) in the first hour
timeFrame: 1 hour
measure: Cardiorespiratory arrest within 24 hours
timeFrame: 24 hours
measure: Deaths with refractory hypoxemia within 7 days
timeFrame: 7 days
measure: Death with refractory acidosis within 7 days
timeFrame: 7 days
measure: Death with barotrauma within 7 days
timeFrame: 7 days
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Alexandre B Cavalcanti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao, Faculdade de Medicina da Universidade de Sao Paulo
name: Carlos RR Carvalho, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Damiani 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.
citation: Writing 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.
citation: Morais 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.
citation: ART 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.