ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Survival in 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- 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 |
Other: ART Strategy
Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
|
| Active Comparator: ARDSNet Strategy |
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 |
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| Contact: Alexandre B Cavalcanti, MD, PhD | +55 11 30536611 ext 8102 | alexandrebiasi@hotmail.com |
| 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 | |
| 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: | March 15, 2012 |
| 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 May 23, 2013