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Clinical Trials/NCT01374022
NCT01374022
Completed
Not Applicable

Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS

Hospital do Coracao1 site in 1 country1,013 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Adult
Sponsor
Hospital do Coracao
Enrollment
1013
Locations
1
Primary Endpoint
Survival in 28 days
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
December 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Survival in 28 days

Time Frame: 28 days

Survival within 28 days from randomization

Secondary Outcomes

  • In-hospital survival(Maximum 6-months)
  • Days free of mechanical ventilation(28 days)
  • ICU survival(Maximum 6-months)
  • Pneumothorax requiring drainage(7 days)
  • Lenght of ICU stay(Maximum 6-months)
  • Barotrauma(7 days)
  • 6-month survival(6 months)
  • Lenght of hospital stay(Maximum 6 months)

Study Sites (1)

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