Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome

NCT05658692 | Unknown Phase 4

• 1 other identifier: 2022-0770
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; ICU; domain; platform adaptive embedded trial

Outcome Measures

Primary Outcomes (1)

• ventilator-free days

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

  within 28 days

Secondary Outcomes (12)

• Clinical status assessment

  15 days

• All-Cause Mortality

  within 28 days

• Duration of mechanical ventilation

  within 28 days

• Sequential Organ Failure Assessment (SOFA) Score

  at 48 hours, 72 hours, and 7 days after randomization

• ICU stay time

  within 90 days

Study Arms (14)

protective ventilation

EXPERIMENTAL

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).

Device: protective ventilation

prone position ventilation (including awake state)

EXPERIMENTAL

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.

Behavioral: prone position ventilation

glucocorticoid therapy

EXPERIMENTAL

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

Drug: glucocorticoid therapy

restrictive fluid resuscitation

EXPERIMENTAL

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.

Other: restrictive fluid resuscitation

Immunomodulatory therapy

EXPERIMENTAL

Thymosin Alpha（Thymalfasin for Injection） 1.6mg subcutaneously twice a week.

Biological: Thymosin Alpha

Muscle relaxant therapy

EXPERIMENTAL

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.

Drug: Muscle relaxant therapy

Integrated Chinese and Western Medicine Treatment

EXPERIMENTAL

Mechanical ventilation + conventional western medicine + Dachengqi Decoction/Rhubarb-Salvia Injection/Tanreqing/Xuanbai Chengqi Decoction(Drugs determined by syndrome differentiation and treatment)

Other: Integrated Chinese and Western Medicine Treatment

statin therapy

EXPERIMENTAL

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.

Drug: statin therapy

anti-infective treatment

EXPERIMENTAL

Refer to the "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021." recommendations.

Combination Product: anti-infective treatment

Extracorporeal Membrane Oxygenation（ECMO）

EXPERIMENTAL

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.

Device: Extracorporeal Membrane Oxygenation（ECMO）

stem cell therapy

EXPERIMENTAL

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.

Genetic: stem cell therapy

Sedative analgesia/muscle relaxant therapy

EXPERIMENTAL

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）.

Drug: Sedative analgesia/muscle relaxant therapy

inotropes therapy

EXPERIMENTAL

For unconventional medication, according to"Surviving sepsis campaign: international guidelines for the management of sepsis and septic shock 2021".

Drug: inotropes therapy

Vasoactive drug therapy

EXPERIMENTAL

According to"Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".

Drug: Vasoactive drug therapy

Interventions

protective ventilation DEVICE

Patients with moderate to severe ARDS received ventilation treatment according to predicted body weight(PBW) and controlled plateau pressure.

protective ventilation

prone position ventilation BEHAVIORAL

patients with moderate to severe ARDS who don't have contraindications were given prone ventilation for over 12 hours.

prone position ventilation (including awake state)

glucocorticoid therapy DRUG

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).

Also known as: Dexamethasone, Hydrocortisone

glucocorticoid therapy

restrictive fluid resuscitation OTHER

1. without other organ dysfunction patients: Minimize fluid was given; 2. 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.

restrictive fluid resuscitation

Thymosin Alpha BIOLOGICAL

People received thymosin Alpha subcutaneous injections, twice a week.

Immunomodulatory therapy

Muscle relaxant therapy DRUG

Deep sedation combined with intermittent bolus injection of muscle relaxant or deep sedation combined with continuous infusion of muscle relaxant

Also known as: Vecuronium Bromide, Succinylcholine

Muscle relaxant therapy

Integrated Chinese and Western Medicine Treatment OTHER

1. ventilation; 2. conventional western medicine treatment； 3. Chinese herbal medicine（Determining medication based on syndrome differentiation）

Integrated Chinese and Western Medicine Treatment

statin therapy DRUG

1. Simvastatin: 80mg qd po for not more than 28days; 2. Rosuvastatin: 20mg qd po (40mg for the first time) for 28days or 3 days after transfer out of the ICU, or the patient died.

Also known as: Simvastatin, Rosuvastatin

statin therapy

anti-infective treatment COMBINATION_PRODUCT

According to "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".

anti-infective treatment

Extracorporeal Membrane Oxygenation（ECMO） DEVICE

1. For severe ARDS patients with refractory hypoxemia within 7 days of onset; 2. (Inspiratory oxygen concentration) ≥ 0.80, tidal volume 6ml/kg (PBW), positive end-expiratory pressure \[PEEP\] ≥ 10 cmH2O; 3. V-V Model.

Extracorporeal Membrane Oxygenation（ECMO）

stem cell therapy GENETIC

A single injection of bone marrow stem cells, doses of 1, 5, 10\*106 cells/kg was taken according to the previous clinical studies.

stem cell therapy

Sedative analgesia/muscle relaxant therapy DRUG

Deep sedation combined with intermittent bolus injection of muscle relaxant or deep sedation combined with continuous infusion of muscle relaxant

Also known as: Propofol, midazolam, dexmedetomidine

Sedative analgesia/muscle relaxant therapy

inotropes therapy DRUG

According to "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".

Also known as: Dopamine, Olprinone, Levosimendan

inotropes therapy

Vasoactive drug therapy DRUG

According to "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".

Also known as: Norepinephrine, epinephrine, metaraminol, isoproterenol

Vasoactive drug therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Renmin Hospital of Wuhan University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• West China Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking Union Medical College Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Fudan University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator

Study Sites (11)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

West China Hospital，Sichuan University

Chengdu, China

RECRUITING

Guangdong Provincial People's Hospital

Guangdong, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

RECRUITING

Lanxi People's Hospital

Lanxi, China

RECRUITING

Ningbo First Hospital

Ningbo, China

RECRUITING

Zhognshang hospital, Fudan University

Shanghai, China

RECRUITING

Taizhou Hosptial of Zhejiang Province

Taizhou, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Wuhan University Renmin Hospital

Wuhan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

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MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Dexamethasone; Hydrocortisone; 3-hydroxyphenyltrimethylammonium; Vecuronium Bromide; Succinylcholine; Simvastatin; Rosuvastatin Calcium; Extracorporeal Membrane Oxygenation; Propofol; Midazolam; Dexmedetomidine; Dopamine; olprinone; Simendan; Norepinephrine; Epinephrine; Metaraminol; Isoproterenol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Androstanols; Androstanes; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Phenols; Benzene Derivatives; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Hydrazones; Hydrazines; Pyridazines; Ethanolamines; Amino Alcohols; Alcohols; Phenylpropanolamine; Propanolamines; Propanols

Study Officials

• Zhaocai Zhang, Doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Zhaocai Zhang, Doctor

CONTACT

+86-13758131998; 2313003@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 21, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be permanently available after the publication of this study.
• 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.

Locations

CN (11)