Flow-flow ECCO2-R and 4 ml/kg Tidal Volume vs. 6 ml/kg Tidal Volume to Enhance Protection From VILI in Acute Lung Injury (ELP)

University of Turin

Status and phase

Terminated

Phase 3

Conditions

Acute Respiratory Distress Syndrome

Treatments

Other: ARDS-Net Strategy

Other: ECCO2-R

Study type

Interventional

Funder types

Other

Identifiers

NCT01522599

ELP-CEI315

Details and patient eligibility

About

The main objective of this randomized multicenter clinical trial is to test the hypothesis that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as compared to the conventional "ARDS-Net" ventilation. Control of PaCO2 in the ~4 ml/kg arm would be accomplished by LFPPV- ECCO2-R.

Full description

The trial will test the hypothesis that a VT of 4 ml/kg PBW combined with low flow CO2 removal improves outcome in patients with severe ARDS (PFs ≤ 200 and PEEP ≥ 10) compared to ventilation with a VT of 6 ml/kg PBW. The study will accrue a maximum of 230 patients over approximately 12-18 months.

PRIMARY END-POINT: Number of ventilator-free days (VFDs) during the 28 days immediately after randomization

SECONDARY END-POINTS: 28 and 90-day all-cause mortality; number of ICU-free days during the 28 days immediately after randomization; cumulative incidence of: first episode of refractory hypoxemia (during 28 days after randomization), use of rescue therapies, first day that meet criteria for weaning, SOFA-free and severe adverse events.

Patients in CONTROL will be treated according to a modified, simplified version of The ARDS-Network lung protective lower tidal volume. Patients in TREATMENT group will be treated according to the ARDS-Net protocol modified (VT reduced by 1 ml/kg PBW at intervals ≤ 2 hours until VT = 4ml/kg PBW and the use of low-flow CO2 removal with a Plateau Pressure Goal: ≤ 25 cm H2O).

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age > 18 years
are on invasive assisted breathing less then 48 hours
less than 24 hours since diagnosis for ARDS: with PF<=200 and PEEP>=10, bilateral infiltrate on chest X-Ray and no clinical evidence of left atrial hypertension
have a commitment to full support

Exclusion criteria

intubation and mechanical ventilation (any form) for > 48 hours
risk of systemic bleeding with anticoagulation
acute brain injury
body mass index > 40
neuromuscular disease that impairs ability to ventilate without assistance
severe chronic respiratory disease
burns > 40% total body surface area
malignancy or other irreversible disease or condition for which 6- month mortality is estimated to be greater than 50%
allogeneic bone marrow transplant within the last 5 years
chronic respiratory condition making patient respirator dependent
patient, surrogate, or physician not committed to full support
acute myocardial infarction or acute coronary syndrome within 30 days
moribund patient: not expected to survive 24 hours
no consent/inability to obtain consent
patients receiving high frequency ventilation