ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospital do Coracao
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01374022
First received: June 13, 2011
Last updated: February 26, 2014
Last verified: February 2014
  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 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 ARDS less than 72hours. Patients will be excluded if they are less than 18 years old, in use of vasopressors drugs in increasing doses over the last 2 hours or mean arterial blood pressure less than 65mmHg, presence of any contraindication to hypercapnia, undrained pneumothorax or subcutaneous emphysema and lack of consent from patient's surrogate to participation. 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: Maximum 6 months ] [ Designated as safety issue: No ]
  • Pneumothorax requiring drainage [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Barotrauma [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Any pneumothorax, pnaumomediastinum, subcutaneous emphysema or pneumatocele greater than 2cm after randomization.

  • Days free of mechanical ventilation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Survival in 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1620
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients mechanically ventilated with diagnosis of ARDS less than 72 hours

Exclusion Criteria:

  • less than 18 years old
  • use of vasopressor drugs in increasing doses over the last 72 hours or mean arterial blood pressure less than 65mmHg
  • presence of any contraindication to hypercapnia as intracranial hypertension or acute coronary syndrome
  • undrained pneumothorax or subcutaneous emphysema
  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

Contacts
Contact: Alexandre B Cavalcanti, MD, PhD +55 11 30536611 ext 8102 alexandrebiasi@hotmail.com

Locations
Brazil
Hospital do Coracao Recruiting
Sao Paulo, SP, Brazil, 04005-000
Contact: Alexandre B Cavalcanti, MD, PhD    +55 11 30536611 ext 8102    alexandrebiasi@hotmail.com   
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

No publications provided by Hospital do Coracao

Additional 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: February 26, 2014
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 20, 2014