ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Sponsor
Hospital do Coracao (Other)
Overall Status
Completed
CT.gov ID
NCT01374022
Collaborator
(none)
1,013
1
2
78
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ART Strategy
  • Other: ARDSNet Strategy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1013 participants
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
Actual Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Survival in 28 days [28 days]

    Survival within 28 days from randomization

Secondary Outcome Measures

  1. Lenght of ICU stay [Maximum 6-months]

    Length of hospital stay from randomization to ICU discharge

  2. Lenght of hospital stay [Maximum 6 months]

    Length of hospital stay from randomization to hospital discharge

  3. Pneumothorax requiring drainage [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 [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 [28 days]

    Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.

  6. ICU survival [Maximum 6-months]

    Survival at ICU discharge.

  7. In-hospital survival [Maximum 6-months]

    Survival at hospital discharge.

  8. 6-month survival [6 months]

    Survival within 6 months after randomization

Other Outcome Measures

  1. Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour; [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 [1 hour]

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

  3. Severe acidosis (pH < 7.10) in the first hour [1 hour]

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

  4. Cardiorespiratory arrest within 24 hours [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01374022
Other Study ID Numbers:
  • CAAE - 0025.1.160.000-11
First Posted:
Jun 15, 2011
Last Update Posted:
Sep 11, 2020
Last Verified:
Sep 1, 2020

Study Results

No Results Posted as of Sep 11, 2020