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ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01374022
First received: June 13, 2011
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Respiratory Distress Syndrome, Adult Other: ART Strategy Other: ARDSNet Strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Survival in 28 days [ Time Frame: 28 days ]
    Survival within 28 days from randomization


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 1013
Actual Study Start Date: June 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374022

Locations
Brazil
Hospital do Coracao
Sao Paulo, SP, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01374022     History of Changes
Other Study ID Numbers: CAAE - 0025.1.160.000-11
Study First Received: June 13, 2011
Last Updated: May 8, 2017

Keywords provided by Hospital do Coracao:
Respiratory Distress Syndrome, Adult
Randomized Controlled Trial
Respiration, Artificial

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on September 20, 2017