Flow-flow ECCO2-R and 4 ml/kg Tidal Volume vs. 6 ml/kg Tidal Volume to Enhance Protection From Ventilator Induced Lung Injury in Acute Lung Injury (ELP)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Number of ventilator-free days during the 28 days immediately after randomization
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of ventilator-free days during the 28 days immediately after randomization
时间窗: 28 DAYS
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.
次要结局
- 28-day all-cause mortality(28 days)
- Cumulative incidence of severe adverse events during 28 days after randomization.(28 days)
- 90-day all-cause mortality.(90 days)
- Cumulative incidence of first episode of refractory hypoxemia (during 28 days after randomization).(28 days)
- Number of ICU-free days during the 28 days immediately after randomization (ICU-FD).(28 days)
- Cumulative SOFA-free score between randomization and day 28.(28 days)
- Cumulative incidence of the use of rescue therapies.(28 days)
- Cumulative incidence of first day that meet criteria for weaning readiness during 28 days after randomization.(28 days)
研究者
Marco Ranieri
Principal Investigator
University of Turin, Italy