Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome

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

Interventions

DEVICE

protective ventilation

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

BEHAVIORAL

prone position ventilation

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

DRUG

glucocorticoid therapy

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).

OTHER

restrictive fluid resuscitation

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.

BIOLOGICAL

Thymosin Alpha

People received thymosin Alpha subcutaneous injections, twice a week.

DRUG

Muscle relaxant therapy

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

OTHER

Integrated Chinese and Western Medicine Treatment

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

DRUG

statin therapy

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.

COMBINATION_PRODUCT

anti-infective treatment

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

DEVICE

Extracorporeal Membrane Oxygenation（ECMO）

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.

GENETIC

stem cell therapy

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

DRUG

Sedative analgesia/muscle relaxant therapy

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

DRUG

inotropes therapy

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

DRUG

Vasoactive drug therapy

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

Sponsors & Collaborators

• Renmin Hospital of Wuhan University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

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

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Zhaocai Zhang, Doctor · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2023-10-31

Completion

2023-12-31

Countries

• China

Study Locations