Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome (PETARDS)
Acute Respiratory Distress Syndrome
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, ICU, domain, platform adaptive embedded trial
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years and older, regardless of gender) admitted to the ICU with ARDS; Intubation and mechanical ventilation; Moderate/severe ARDS defined by Berlin criteria (PaO2/FiO2 ≤200mmHg, PEEP ≥5cmH20); Moderate/severe ARDS less than 48 hours before randomization. Exclusion Criteria: Pregnancy or breastfeeding; Known allergy to the intervention drug; Daily use of an intervention drug or measure within the past 15 days; Intervention drugs or measures primarily intended to treat other conditions (eg, septic shock); Patients using the intervention drug or standard for two or more days during hospitalization; Patients are expected to die within the next 24 hours; Other: Participated in PETARDS in the past 90 days.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
- West China Hospital,Sichuan UniversityRecruiting
- Guangdong Provincial People's HospitalRecruiting
- The Second Affiliated Hospital of Harbin Medical UniversityRecruiting
- Lanxi People's HospitalRecruiting
- Ningbo First HospitalRecruiting
- Zhognshang hospital, Fudan UniversityRecruiting
- Taizhou Hosptial of Zhejiang ProvinceRecruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Wuhan University Renmin HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
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protective ventilation
prone position ventilation (including awake state)
glucocorticoid therapy
restrictive fluid resuscitation
Immunomodulatory therapy
Muscle relaxant therapy
Integrated Chinese and Western Medicine Treatment
statin therapy
anti-infective treatment
Extracorporeal Membrane Oxygenation(ECMO)
stem cell therapy
Sedative analgesia/muscle relaxant therapy
inotropes therapy
Vasoactive drug therapy
For ARDS patients with moderate to severe mechanical ventilation(MAQUET), give 6-8ml/kg (ideal body weight PBW), and control the plateau pressure to <30cmH2O; In patients with respiratory distress, the tidal volume can be increased to 7-8ml/kg (PBW), while the plateau pressure is <30cmH2O. Adjust breathing rate according to CO2 level, up to 35 breaths/min. PBW, male: 50+0.91 (height cm-152.4); female: 45.5+0.91 (height cm-152.4).
For patients with moderate to severe ARDS who have no contraindications to prone ventilation, protective lung ventilation is given and prone ventilation is performed; the duration is more than 12 hours/time.
Glucocorticoids are used for ARDS patients, with small doses and short courses of treatment in the acute phase (within 14 days). There is no clear recommendation for patients with ARDS from other causes. At present, the main research methods are methylprednisolone program(Solu-Medrol®), dexamethasone program, and hydrocortisone program
ARDS patients with circulatory or organ hypoperfusion problems should use as little fluid as possible to maintain treatment and circulation; other ARDS patients should focus on stabilizing circulation during the resuscitation phase, with controlled fluid replacement combined with early vasoactive drugs; ultrasound, Central venous pressure measurement, mixed central venous oxygen saturation, alveolar-arterial oxygen difference, blood lactate, etc. guide fluid resuscitation therapy; stop using vasoactive drugs for more than 12 hours, and use diuretics or diuretics combined with albumin to achieve fluid balance.
Thymosin Alpha(Thymalfasin for Injection) 1.6mg subcutaneously twice a week.
For patients with moderate to severe ARDS, if light sedation cannot achieve protective lung ventilation strategy and prone position ventilation, deep sedation combined with intermittent bolus injection of muscle relaxants(Vecuronium Bromide for Injection) is used; if protective lung ventilation strategy and prone position ventilation still cannot be achieved, deep sedation combined with continuous Inject muscle relaxants.
Mechanical ventilation + conventional western medicine + Dachengqi Decoction/Rhubarb-Salvia Injection/Tanreqing/Xuanbai Chengqi Decoction(Drugs determined by syndrome differentiation and treatment)
There are currently two options: 1) Simvastatin (Simvastatin Tablets)80 mg QD orally for up to 28 days in patients with acute lung injury. 2) Rosuvastatin (Rosuvastatin Calcium Tablets)40 mg for the first time, followed by 20 mg orally daily for 28 days, or 3 days after being transferred out of the ICU, or after the patient died.
Refer to the "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021." recommendations.
ECMO (Medtronic) is chosen as rescue therapy for severe ARDS patients with refractory hypoxemia within 7 days of onset. (Oxygenation index < 50 mmHg for 3 hours, or oxygenation index < 80 mmHg for 6 hours, or arterial pH < 7.25, arterial partial pressure of carbon dioxide [Paco2] ≥ 60 mmHg > 6 hours, and respiratory rate increased to every minute 35 breaths, adjusting mechanical ventilation settings to maintain plateau pressure ≤32 cmH2O) despite ventilator optimization (defined as inspired oxygen concentration) ≥ 0.80, tidal volume 6 ml/kg (PBW), and positive end-expiratory pressure [PEEP] ≥ 10 cmH2O). V-V mode is preferred.
Previous clinical studies have found that stem cell therapy is safe, using a single injection of bone marrow stem cells at a dose of 1, 5, 10*106 cells/kg; START trial, ClinicalTrials.gov NCT02097641, for patients with moderate to severe ARDS, a single intravenous injection of bone marrow stem cells 10* 106 cells/kg intervention protocol.
For patients with moderate to severe ARDS, if light sedation cannot achieve protective lung ventilation strategy and prone position ventilation, deep sedation(Propofol Injectable Emulsion or Midazolam Injection) combined with intermittent bolus injection of muscle relaxants is used; if protective lung ventilation strategy and prone position ventilation still cannot be achieved, deep sedation combined with continuous Inject muscle relaxants(Vecuronium Bromide for Injection).
For unconventional medication, according to"Surviving sepsis campaign: international guidelines for the management of sepsis and septic shock 2021".
According to"Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".