ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Respiratory Distress Syndrome, Adult Clinical Trial

— ART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374022
• Other study ID #: CAAE - 0025.1.160.000-11
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2017

Study information

• Verified date: September 2020
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1013
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• ART Strategy
Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
• ARDSNet Strategy
Conventional mechanical ventilation strategy.

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour;	Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour after randomization.	1 hour
Other	Hypoxemia (PaO2 < 55mmHg) in the first hour	Hypoxemia (PaO2 < 55mmHg) in the first hour after randomization	1 hour
Other	Severe acidosis (pH < 7.10) in the first hour	Severe acidosis (pH < 7.10) in the first hour after randomization	1 hour
Other	Cardiorespiratory arrest within 24 hours	Cardiorespiratory arrest defined as unexpected cardiac arrest, not due to progressive refractory shock within 24 hours after randomization.	24 hours
Other	Deaths with refractory hypoxemia within 7 days	Death with refractory hypoxemia, defined as PaO2 < 55 mmHg in the last arterial blood gas analysis with FiO2 = 100%.	7 days
Other	Death with refractory acidosis within 7 days	Death with refractory acidosis within 7 days, defined as pH = 7.10 in the last arterial blood gas analysis	7 days
Other	Death with barotrauma within 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.	7 days
Primary	Survival in 28 days	Survival within 28 days from randomization	28 days
Secondary	Lenght of ICU stay	Length of hospital stay from randomization to ICU discharge	Maximum 6-months
Secondary	Lenght of hospital stay	Length of hospital stay from randomization to hospital discharge	Maximum 6 months
Secondary	Pneumothorax requiring drainage	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.	7 days
Secondary	Barotrauma	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.	7 days
Secondary	Days free of mechanical ventilation	Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.	28 days
Secondary	ICU survival	Survival at ICU discharge.	Maximum 6-months
Secondary	In-hospital survival	Survival at hospital discharge.	Maximum 6-months
Secondary	6-month survival	Survival within 6 months after randomization	6 months