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Completed

NCT Number: NCT01374022

ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

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.

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Key information

Conditions

Respiratory Distress Syndrome, Adult Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital do Coracao

São Paulo, 04005-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ART Strategy

Other

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

ARDSNet Strategy

Other

Conventional mechanical ventilation strategy.

Primary outcomes

  1. Survival in 28 days

    Time frame: 28 days

    Survival within 28 days from randomization

Secondary outcomes

  1. Lenght of ICU stay

    Time frame: Maximum 6-months

    Length of hospital stay from randomization to ICU discharge

  2. Lenght of hospital stay

    Time frame: Maximum 6 months

    Length of hospital stay from randomization to hospital discharge

  3. 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.

  4. 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.

  5. 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.

  6. ICU survival

    Time frame: Maximum 6-months

    Survival at ICU discharge.

  7. In-hospital survival

    Time frame: Maximum 6-months

    Survival at hospital discharge.

  8. 6-month survival

    Time frame: 6 months

    Survival within 6 months after randomization

Other outcomes

  1. 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.

  2. Hypoxemia (PaO2 < 55mmHg) in the first hour

    Time frame: 1 hour

    Hypoxemia (PaO2 < 55mmHg) in the first hour after randomization

  3. Severe acidosis (pH < 7.10) in the first hour

    Time frame: 1 hour

    Severe acidosis (pH < 7.10) in the first hour after randomization

  4. 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.

  5. 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%.

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Acronym: ART

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2011
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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