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

NCT ID: NCT01522599

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-01-31

Brief Summary

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.

Detailed 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).

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARDS-Net strategy (Control)

Group Type: ACTIVE_COMPARATOR

ARDS-Net Strategy

Intervention Type: OTHER

Treatment according to the ARDS-Net protocol (The Acute Respiratory Distress Syndrome Network N Engl J Med 2000; 342:1301-1308May 4, 2000)

ECCO2-R with 4 mL/Kg Vt (Treatment)

Group Type: EXPERIMENTAL

ECCO2-R

Intervention Type: OTHER

Ventilation with Tidal Volume of 4 ml/kg PBW and low flow CO2 removal

Interventions

ARDS-Net Strategy

Treatment according to the ARDS-Net protocol (The Acute Respiratory Distress Syndrome Network N Engl J Med 2000; 342:1301-1308May 4, 2000)

Intervention Type: OTHER

ECCO2-R

Ventilation with Tidal Volume of 4 ml/kg PBW and low flow CO2 removal

Intervention Type: OTHER

Other Intervention Names

Protective ventilation; Further protective ventilation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Ranieri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vito Marco VM Ranieri, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

Antonio A Pesenti, MD

Role: STUDY_CHAIR

Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, Monza, Italy

Locations

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, , Italy

Countries

Italy

Other Identifiers

ELP-CEI315

Identifier Type: -

Identifier Source: org_study_id