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Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome (PETARDS)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
protective ventilation
prone position ventilation
glucocorticoid therapy
restrictive fluid resuscitation
Thymosin Alpha
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
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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".

Outcomes

Primary Outcome Measures

ventilator-free days
Ventilator-free days 28 days after randomization, definition: Survival without mechanical ventilation

Secondary Outcome Measures

Clinical status assessment
Patients' clinical status (6-point scale score) was assessed on day 15 after randomization, Definition: This scale ranges from 1 (no hospitalization) to 6 (death), with higher scores indicating worse outcomes.
All-Cause Mortality
All-cause mortality 28 days after randomization
Duration of mechanical ventilation
days of mechanical ventilation
Sequential Organ Failure Assessment (SOFA) Score
SOFA Score for different times, from 0 to 24 points
ICU stay time
The time for patients staying in ICU when they were in the hospital.
Hospital stay
The whole time patients lived in the hospital, including the time when they lived in the ICU
Organ failure free days
Patients got ARDS, but the other organs were not injury.
Health-related quality of life assessment, EQ5D-5L and WHODAS 2.0
Patient's life quality was assessed according to EQ5D-5L. If the patient had severe impairment of organ function within 6 months, evaluated the patient's quality of life according to WHODAS 2.0
Proportion of intubated patients undergoing tracheostomy
ARDS patients received tracheostomy.
Where the patient went after discharge
Home, rehabilitation hospital, nursing home or long-term care facility, or other emergency hospital
Re-admission to ICU during readmission
Patients were sent to the hospital and sent to the ICU again,
Days not in intensive care unit
ICU transfer and discharge 28 days after randomization

Full Information

First Posted
November 22, 2022
Last Updated
December 13, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Renmin Hospital of Wuhan University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital, The First Affiliated Hospital of Zhengzhou University, Peking Union Medical College Hospital, Wuhan Union Hospital, China, Fudan University, Guangdong Provincial People's Hospital, Ningbo No. 1 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05658692
Brief Title
Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome
Acronym
PETARDS
Official Title
Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Renmin Hospital of Wuhan University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital, The First Affiliated Hospital of Zhengzhou University, Peking Union Medical College Hospital, Wuhan Union Hospital, China, Fudan University, Guangdong Provincial People's Hospital, Ningbo No. 1 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Platform adaptive embedded trial for acute respiratory distress syndrome (PETARDS) is a randomized, embedded, multifactorial, adaptive platform trial for ARDS. The study aimed to assess the impact of multiple interventions on outcomes in patients with ARDS admitted to the ICU.
Detailed Description
Mortality is significantly higher in ARDS patients requiring intensive care unit (ICU) admission. ARDS patients admitted to the ICU typically receive multiple (as many as 10 or 20) treatments that work together to fight infection, reduce pulmonary exudation, improve oxygenation, and support systemic organ function. Clinicians are often willing to choose the exact or considered safe and effective regimen from the therapies mentioned above. Still, there are individual differences in ARDS patients, and it is difficult to confirm the optimal treatment plan. It is inevitable to choose treatment without evidence-based medicine based on experience. The primary purpose of this study was to help physicians select the best-effective approach among existing ARDS therapies, and secondly to provide a rationale for specific empirical or emerging ARDS treatments. Clinical evidence to guide optimal management is best obtained from randomized controlled trials (RCTs); however, ARDS is a multi-causal, clinically and therapeutically heterogeneous clinical syndrome with rapid disease progression and complex clinical manifestations, in fact, difficult to organize RCT trials. In cases where the timing of onset and the pathophysiological mechanism cannot be determined, the initial treatment is the selection of protective ventilation/controlled infusion as the first-line standard therapy according to the Berlin classification of ARDS, and some second-line treatments with potential clinical benefit. It is difficult to conduct objective, scientific and timely evaluation, and the overall treatment plan is inevitably blind and empirical. This clinical operation mode is likely related to ARDS-related RCT research results. The results are unsatisfactory, the treatment response heterogeneity is high, and the outcome events vary greatly. closely related to the clinical status. The adaptive platform trial PETARDS is ideal for evaluating the effects of highly heterogeneous ARDS treatment strategies. This clinical research design (adaptive platform trial, APT) can use the information of patients who are participating in the study to guide the clinical treatment of subsequent newly enrolled patients. The APT trial randomized patients into multiple domains for multiple interventions to assess their effectiveness in different patients. The term "domain" refers to a common treatment unit (eg, steroid therapy) within which patients can be randomly assigned to several interventional (dose) groups (including controls, such as no steroids, as appropriate). Certainly). All trial procedures consist of a primary or "core" protocol and multiple secondary protocols, and the standard protocols, clinical treatment adaptations, and trial management and practices for specific treatment units are managed in a unified manner for each treatment unit. The core protocol, secondary protocols, and Statistical Analysis Plan (SAP) of this trial are presented in the appendix; the study required approval from the relevant ethics committees of all participating hospitals and was conducted by good clinical practice guidelines and principles described in the Declaration of Helsinki.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, ICU, domain, platform adaptive embedded trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
protective ventilation
Arm Type
Experimental
Arm Description
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).
Arm Title
prone position ventilation (including awake state)
Arm Type
Experimental
Arm Description
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.
Arm Title
glucocorticoid therapy
Arm Type
Experimental
Arm Description
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
Arm Title
restrictive fluid resuscitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Immunomodulatory therapy
Arm Type
Experimental
Arm Description
Thymosin Alpha(Thymalfasin for Injection) 1.6mg subcutaneously twice a week.
Arm Title
Muscle relaxant therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Integrated Chinese and Western Medicine Treatment
Arm Type
Experimental
Arm Description
Mechanical ventilation + conventional western medicine + Dachengqi Decoction/Rhubarb-Salvia Injection/Tanreqing/Xuanbai Chengqi Decoction(Drugs determined by syndrome differentiation and treatment)
Arm Title
statin therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
anti-infective treatment
Arm Type
Experimental
Arm Description
Refer to the "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021." recommendations.
Arm Title
Extracorporeal Membrane Oxygenation(ECMO)
Arm Type
Experimental
Arm Description
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.
Arm Title
stem cell therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sedative analgesia/muscle relaxant therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
inotropes therapy
Arm Type
Experimental
Arm Description
For unconventional medication, according to"Surviving sepsis campaign: international guidelines for the management of sepsis and septic shock 2021".
Arm Title
Vasoactive drug therapy
Arm Type
Experimental
Arm Description
According to"Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Intervention Type
Device
Intervention Name(s)
protective ventilation
Intervention Description
Patients with moderate to severe ARDS received ventilation treatment according to predicted body weight(PBW) and controlled plateau pressure.
Intervention Type
Behavioral
Intervention Name(s)
prone position ventilation
Intervention Description
patients with moderate to severe ARDS who don't have contraindications were given prone ventilation for over 12 hours.
Intervention Type
Drug
Intervention Name(s)
glucocorticoid therapy
Other Intervention Name(s)
Dexamethasone, Hydrocortisone
Intervention Description
Dexamethasone: Patients received intravenous dexamethasone 20 mg daily from days 1 to 5, reduced to 10 mg daily from days 6 to 10. Hydrocortisone:For septic ARDS patients, 50 mg of hydrocortisone was given as an intravenous bolus every 6 hours for 7 days; For patients with COVID-19-related ARDS, The corticosteroid field randomized participants to a fixed 7-day period of intravenous hydrocortisone (50 mg or 100 mg every 6 hours).
Intervention Type
Other
Intervention Name(s)
restrictive fluid resuscitation
Intervention Description
without other organ dysfunction patients: Minimize fluid was given; other ARDS patients: In the resuscitation phase, controlled fluid replacement combined with vasoactive drugs was given; multiple measures were taken, like lactate and so on, to utilizedto guide fluid resuscitation therapy; diuretics or diuretics in combination with albumin to achieve fluid balance.
Intervention Type
Biological
Intervention Name(s)
Thymosin Alpha
Intervention Description
People received thymosin Alpha subcutaneous injections, twice a week.
Intervention Type
Drug
Intervention Name(s)
Muscle relaxant therapy
Other Intervention Name(s)
Vecuronium Bromide, Succinylcholine
Intervention Description
Deep sedation combined with intermittent bolus injection of muscle relaxant or deep sedation combined with continuous infusion of muscle relaxant
Intervention Type
Other
Intervention Name(s)
Integrated Chinese and Western Medicine Treatment
Intervention Description
ventilation; conventional western medicine treatment; Chinese herbal medicine(Determining medication based on syndrome differentiation)
Intervention Type
Drug
Intervention Name(s)
statin therapy
Other Intervention Name(s)
Simvastatin, Rosuvastatin
Intervention Description
Simvastatin: 80mg qd po for not more than 28days; Rosuvastatin: 20mg qd po (40mg for the first time) for 28days or 3 days after transfer out of the ICU, or the patient died.
Intervention Type
Combination Product
Intervention Name(s)
anti-infective treatment
Intervention Description
According to "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Intervention Type
Device
Intervention Name(s)
Extracorporeal Membrane Oxygenation(ECMO)
Intervention Description
For severe ARDS patients with refractory hypoxemia within 7 days of onset; (Inspiratory oxygen concentration) ≥ 0.80, tidal volume 6ml/kg (PBW), positive end-expiratory pressure [PEEP] ≥ 10 cmH2O; V-V Model.
Intervention Type
Genetic
Intervention Name(s)
stem cell therapy
Intervention Description
A single injection of bone marrow stem cells, doses of 1, 5, 10*106 cells/kg was taken according to the previous clinical studies.
Intervention Type
Drug
Intervention Name(s)
Sedative analgesia/muscle relaxant therapy
Other Intervention Name(s)
Propofol, midazolam, dexmedetomidine
Intervention Description
Deep sedation combined with intermittent bolus injection of muscle relaxant or deep sedation combined with continuous infusion of muscle relaxant
Intervention Type
Drug
Intervention Name(s)
inotropes therapy
Other Intervention Name(s)
Dopamine, Olprinone, Levosimendan
Intervention Description
According to "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Intervention Type
Drug
Intervention Name(s)
Vasoactive drug therapy
Other Intervention Name(s)
Norepinephrine, epinephrine, metaraminol, isoproterenol
Intervention Description
According to "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Primary Outcome Measure Information:
Title
ventilator-free days
Description
Ventilator-free days 28 days after randomization, definition: Survival without mechanical ventilation
Time Frame
within 28 days
Secondary Outcome Measure Information:
Title
Clinical status assessment
Description
Patients' clinical status (6-point scale score) was assessed on day 15 after randomization, Definition: This scale ranges from 1 (no hospitalization) to 6 (death), with higher scores indicating worse outcomes.
Time Frame
15 days
Title
All-Cause Mortality
Description
All-cause mortality 28 days after randomization
Time Frame
within 28 days
Title
Duration of mechanical ventilation
Description
days of mechanical ventilation
Time Frame
within 28 days
Title
Sequential Organ Failure Assessment (SOFA) Score
Description
SOFA Score for different times, from 0 to 24 points
Time Frame
at 48 hours, 72 hours, and 7 days after randomization
Title
ICU stay time
Description
The time for patients staying in ICU when they were in the hospital.
Time Frame
within 90 days
Title
Hospital stay
Description
The whole time patients lived in the hospital, including the time when they lived in the ICU
Time Frame
within 90 days
Title
Organ failure free days
Description
Patients got ARDS, but the other organs were not injury.
Time Frame
within 28 days
Title
Health-related quality of life assessment, EQ5D-5L and WHODAS 2.0
Description
Patient's life quality was assessed according to EQ5D-5L. If the patient had severe impairment of organ function within 6 months, evaluated the patient's quality of life according to WHODAS 2.0
Time Frame
within 6 months
Title
Proportion of intubated patients undergoing tracheostomy
Description
ARDS patients received tracheostomy.
Time Frame
28 days
Title
Where the patient went after discharge
Description
Home, rehabilitation hospital, nursing home or long-term care facility, or other emergency hospital
Time Frame
No recurrence within 90 days
Title
Re-admission to ICU during readmission
Description
Patients were sent to the hospital and sent to the ICU again,
Time Frame
within 90 days
Title
Days not in intensive care unit
Description
ICU transfer and discharge 28 days after randomization
Time Frame
28 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaocai Zhang, Doctor
Phone
+86-13758131998
Email
2313003@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaocai Zhang, Doctor
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yecheng liu
Facility Name
West China Hospital,Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shu zhang
Facility Name
Guangdong Provincial People's Hospital
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yiyu deng
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junbo Zheng
Facility Name
Lanxi People's Hospital
City
Lanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiancheng ducheng
Facility Name
Ningbo First Hospital
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
heng fan
Facility Name
Zhognshang hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhenju songzhen
Facility Name
Taizhou Hosptial of Zhejiang Province
City
Taizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sheng zhang
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yujing zhang
Facility Name
Wuhan University Renmin Hospital
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chao lan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD; all IPD that underlie results in a publication.
IPD Sharing Time Frame
Data will be permanently available after the publication of this study.
IPD Sharing Access Criteria
Data will be made available to all upon publication of this study. Applicants can contact the corresponding author to apply, but they must provide the reasons for the application, the purpose of the research, and the ethical certificates of the relevant research.
Citations:
PubMed Identifier
34599691
Citation
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
Results Reference
background
PubMed Identifier
10793162
Citation
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
Results Reference
background
PubMed Identifier
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Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome

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