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

NCT01522599 | Terminated Phase 3 DMC

• 1 other identifier: ELP-CEI315
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS: Acute Respiratory Distress Syndrome; LOW FLOW ECCO2-R: EXTRA-CORPOREAL CO2 REMOVAL; VILI: Ventilator Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Number of ventilator-free days during the 28 days immediately after randomization

  VFDs is a composite endpoint. VFD to day 28 is defined as the number of days after initiating unassisted breathing to day 28 after randomization, assuming a patient survives for at least two consecutive calendar days after initiating nassisted breathing and remains free of assisted breathing. If a patient dies prior to day 28 or is still receiving assisted breathing at day 27, his/her VFDs will be zero.

  28 DAYS

Secondary Outcomes (8)

• 28-day all-cause mortality

  28 days

• 90-day all-cause mortality.

  90 days

• Number of ICU-free days during the 28 days immediately after randomization (ICU-FD).

  28 days

• Cumulative incidence of first episode of refractory hypoxemia (during 28 days after randomization).

  28 days

• Cumulative incidence of the use of rescue therapies.

  28 days

Study Arms (2)

ARDS-Net strategy (Control)

ACTIVE COMPARATOR

Other: ARDS-Net Strategy

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

EXPERIMENTAL

Other: ECCO2-R

Interventions

ARDS-Net Strategy OTHER

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

Also known as: Protective ventilation

ARDS-Net strategy (Control)

ECCO2-R OTHER

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

Also known as: Further protective ventilation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Vito Marco VM Ranieri, MD

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

  PRINCIPAL INVESTIGATOR

• Antonio A Pesenti, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

IT (1)