Domain Lead Investigators
Resources
- Download 2. ULTIMATE Domain Protocol (pdf:660KB)
- Download 1. ULTIMATE Protocol Summary (pdf:177KB)
Domain Description
Objective | The primary objective of the full ULTIMATE trial will be to determine the effect of ultra-protective ventilation facilitated by CO2 removal through VV-ECMO versus best current standard ventilation on all-cause hospital mortality among patients with early moderate-severe hypoxemic respiratory failure with high respiratory system elastance. Feasibility objectives of the ULTIMATE Pilot RCT are to assess adequacy of patient recruitment, adherence to specific ventilation protocols and rates of crossover between groups. This pilot RCT will determine whether a RCT of VV ECMO can feasibly be conducted and the degree to which the intervention can facilitate ultra-lung-protective mechanical ventilation in patients with ARDS. If feasibility is demonstrated, investigators will remain blinded to these clinical results and the pilot RCT patients will roll over into the full ULTIMATE trial. |
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Population | This domain will enroll patients receiving invasive mechanical ventilation for early moderate-severe acute hypoxemic respiratory failure (PaO2:FiO2 < 200 mm Hg, <72 hours) in one of the four platform-defined states: high elastance. |
Primary Endpoint | The primary outcome of this pilot study is feasibility. |
Design | The ULTIMATE pilot trial is a multi-centre, randomized, open-label trial, embedded as a domain within the PRACTICAL platform trial. The patient population for this domain includes intubated patients who are not on extracorporeal life support, and have been diagnosed with acute hypoxemic respiratory failure characterized by high lung elastance. This trial will be conducted in compliance with protocol and GCP guidelines. Consenting eligible patients will be randomized to either the intervention ventilation strategy or the control ventilation strategy. Patients in the experimental group will receive ultra-protective ventilation using ECMO. Patients requiring ventilation for longer periods may continue ventilation via ECMO, or receive standard-of-care ventilation, as deemed necessary by the treating physician. The control group will receive the usual standard of care ventilation. If the patient’s clinical status declines and meets the ECMO criteria for ventilation (as established by prior randomized clinical trials), they would be eligible to receive ECMO if their treating physician deemed that appropriate. Study procedures common to both groups will continue for the duration of the ICU stay up to day 30. We will collect daily data during mechanical ventilation until day 30. Thereafter, we will follow patients to the time of hospital discharge and record ICU/hospital survival. We will also assess health related quality of life by telephone interview or via email 6 months after randomization. |
Control Group
Name | Conventional lung-protective ventilation (LPV) |
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Description |
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Target sample size | 72 patients total |
Participating sites | All sites participating in this domain |
Interventions
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Intervention Lead investigators Eligible states Low elastance (invasively ventilated) Description - VV ECMO via single access, dual-lumen Protek Duo cannula
- Tidal volume target of 6 mL/kg predicted body weight
- Plateau airway pressure <30 cm H2O
Stage of evaluation Phase II Primary endpoint Feasibility Active comparator Conventional lung-proteective ventilation Target sample size 30 patients Participating sites All sites participating in this domain