NCT01374022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,013

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

6.5 years

First QC Date

June 13, 2011

Last Update Submit

September 9, 2020

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Respiratory Distress Syndrome, AdultRandomized Controlled TrialRespiration, Artificial

Outcome Measures

Primary Outcomes (1)

  • Survival in 28 days

    Survival within 28 days from randomization

    28 days

Secondary Outcomes (8)

  • Lenght of ICU stay

    Maximum 6-months

  • Lenght of hospital stay

    Maximum 6 months

  • Pneumothorax requiring drainage

    7 days

  • Barotrauma

    7 days

  • Days free of mechanical ventilation

    28 days

  • +3 more secondary outcomes

Other Outcomes (7)

  • Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour;

    1 hour

  • Hypoxemia (PaO2 < 55mmHg) in the first hour

    1 hour

  • Severe acidosis (pH < 7.10) in the first hour

    1 hour

  • +4 more other outcomes

Study Arms (2)

ART Strategy

EXPERIMENTAL

maximum alveolar recruitment plus PEEP titration

Other: ART Strategy

ARDSNet Strategy

ACTIVE COMPARATOR

standard strategy (ARDSNet)

Other: ARDSNet Strategy

Interventions

ART StrategyOTHER

Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.

ART Strategy
ARDSNet StrategyOTHER

Conventional mechanical ventilation strategy.

ARDSNet Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 30961913DERIVED

  • 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.

    PMID: 28977255DERIVED

  • 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.

    PMID: 28973363DERIVED

  • 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.

    PMID: 28409685DERIVED

  • 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.

    PMID: 22929542DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre B Cavalcanti, MD, PhD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

  • Carlos RR Carvalho, MD, PhD

    Hospital do Coracao, Faculdade de Medicina da Universidade de Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 15, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 11, 2020

Record last verified: 2020-09

Locations

BR(1)