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Acute Respiratory Distress SyndromePhase 4PETARDSNCT05658692

Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome

A Phase 4 study testing protective ventilation, prone position ventilation and glucocorticoid therapy in people with Acute Respiratory Distress Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 11 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
protective ventilation, prone position ventilation and glucocorticoid therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
11 sitesChina
Study dates
1 Oct 2022to Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

Zhaocai Zhang, Doctor contact

+86-13758131998

2313003@zju.edu.cn

11 sites in 1 country

China11 sites, 11 recruiting

  • Peking Union Medical College Hospital

    Beijing

    yecheng liu

    Recruiting

  • West China Hospital，Sichuan University

    Chengdu

    shu zhang

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangdong

    yiyu deng

    Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin

    Junbo Zheng

    Recruiting

  • Lanxi People's Hospital

    Lanxi

    jiancheng ducheng

    Recruiting

  • Ningbo First Hospital

    Ningbo

    heng fan

    Recruiting

  • Zhognshang hospital, Fudan University

    Shanghai

    zhenju songzhen

    Recruiting

  • Taizhou Hosptial of Zhejiang Province

    Taizhou

    sheng zhang

    Recruiting

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

    Wuhan

    yujing zhang

    Recruiting

  • Wuhan University Renmin Hospital

    Wuhan

    Lu Wang

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    chao lan

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
protective ventilation, prone position ventilation, glucocorticoid therapy, restrictive fluid resuscitation, Thymosin Alpha
Keywords
ARDS, ICU, domain, platform adaptive embedded trial
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • protective ventilationDevice

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

  • prone position ventilationBehavioural

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

  • glucocorticoid therapyDrug

    Also called Dexamethasone, Hydrocortisone

    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).

  • restrictive fluid resuscitationOther

    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.

  • Thymosin AlphaBiological

    People received thymosin Alpha subcutaneous injections, twice a week.

  • Muscle relaxant therapyDrug

    Also called Vecuronium Bromide, Succinylcholine

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

  • Integrated Chinese and Western Medicine TreatmentOther

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

  • statin therapyDrug

    Also called Simvastatin, Rosuvastatin

    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.

  • anti-infective treatmentCombination product

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

  • 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.

  • stem cell therapyGenetic

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

  • Sedative analgesia/muscle relaxant therapyDrug

    Also called Propofol, midazolam, dexmedetomidine

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

  • inotropes therapyDrug

    Also called Dopamine, Olprinone, Levosimendan

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

  • Vasoactive drug therapyDrug

    Also called Norepinephrine, epinephrine, metaraminol, isoproterenol

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

Study groups in NCT05658692
Study groupRoleWhat they receive
protective ventilationExperimentalFor 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).
Receives: Device: protective ventilation
prone position ventilation (including awake state)ExperimentalFor 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.
Receives: Behavioral: prone position ventilation
glucocorticoid therapyExperimentalGlucocorticoids 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
Receives: Drug: glucocorticoid therapy
restrictive fluid resuscitationExperimentalARDS 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.
Receives: Other: restrictive fluid resuscitation
Immunomodulatory therapyExperimentalThymosin Alpha（Thymalfasin for Injection） 1.6mg subcutaneously twice a week.
Receives: Biological: Thymosin Alpha
Muscle relaxant therapyExperimentalFor 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.
Receives: Drug: Muscle relaxant therapy
Integrated Chinese and Western Medicine TreatmentExperimentalMechanical ventilation + conventional western medicine + Dachengqi Decoction/Rhubarb-Salvia Injection/Tanreqing/Xuanbai Chengqi Decoction(Drugs determined by syndrome differentiation and treatment)
Receives: Other: Integrated Chinese and Western Medicine Treatment
statin therapyExperimentalThere 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.
Receives: Drug: statin therapy
anti-infective treatmentExperimentalRefer to the "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021." recommendations.
Receives: Combination Product: anti-infective treatment
Extracorporeal Membrane Oxygenation（ECMO）ExperimentalECMO (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.
Receives: Device: Extracorporeal Membrane Oxygenation（ECMO）
stem cell therapyExperimentalPrevious 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.
Receives: Genetic: stem cell therapy
Sedative analgesia/muscle relaxant therapyExperimentalFor 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）.
Receives: Drug: Sedative analgesia/muscle relaxant therapy
inotropes therapyExperimentalFor unconventional medication, according to"Surviving sepsis campaign: international guidelines for the management of sepsis and septic shock 2021".
Receives: Drug: inotropes therapy
Vasoactive drug therapyExperimentalAccording to"Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Receives: Drug: Vasoactive drug therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ventilator-free days

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

    Measured: within 28 days

Secondary outcomes (12)

  1. 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.

    Measured: 15 days

  2. All-Cause Mortality

    All-cause mortality 28 days after randomization

    Measured: within 28 days

  3. Duration of mechanical ventilation

    days of mechanical ventilation

    Measured: within 28 days

  4. Sequential Organ Failure Assessment (SOFA) Score

    SOFA Score for different times, from 0 to 24 points

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

  5. ICU stay time

    The time for patients staying in ICU when they were in the hospital.

    Measured: within 90 days

  6. Hospital stay

    The whole time patients lived in the hospital, including the time when they lived in the ICU

    Measured: within 90 days

  7. Organ failure free days

    Patients got ARDS, but the other organs were not injury.

    Measured: within 28 days

  8. 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

    Measured: within 6 months

  9. Proportion of intubated patients undergoing tracheostomy

    ARDS patients received tracheostomy.

    Measured: 28 days

  10. Where the patient went after discharge

    Home, rehabilitation hospital, nursing home or long-term care facility, or other emergency hospital

    Measured: No recurrence within 90 days

  11. Re-admission to ICU during readmission

    Patients were sent to the hospital and sent to the ICU again,

    Measured: within 90 days

  12. Days not in intensive care unit

    ICU transfer and discharge 28 days after randomization

    Measured: 28 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start1 Oct 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658692
Sponsor's protocol ID
2022-0770
Acronym
PETARDS
Status last verified
Nov 2022
First submitted
22 Nov 2022
Last updated
21 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 1. all collected IPD； 2. all IPD that underlie results in a publication.

Publications

  • 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.

    PubMed 34599691

  • 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.

    PubMed 10793162

  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PubMed 23688302

  • Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21.

    PubMed 28940011

  • Meduri GU, Annane D, Confalonieri M, Chrousos GP, Rochwerg B, Busby A, Ruaro B, Meibohm B. Pharmacological principles guiding prolonged glucocorticoid treatment in ARDS. Intensive Care Med. 2020 Dec;46(12):2284-2296. doi: 10.1007/s00134-020-06289-8. Epub 2020 Nov 4.

    PubMed 33150472

  • Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7.

    PubMed 32043986

  • Vignon P, Evrard B, Asfar P, Busana M, Calfee CS, Coppola S, Demiselle J, Geri G, Jozwiak M, Martin GS, Gattinoni L, Chiumello D. Fluid administration and monitoring in ARDS: which management? Intensive Care Med. 2020 Dec;46(12):2252-2264. doi: 10.1007/s00134-020-06310-0. Epub 2020 Nov 9.

    PubMed 33169217

  • Malbrain MLNG, Van Regenmortel N, Saugel B, De Tavernier B, Van Gaal PJ, Joannes-Boyau O, Teboul JL, Rice TW, Mythen M, Monnet X. Principles of fluid management and stewardship in septic shock: it is time to consider the four D's and the four phases of fluid therapy. Ann Intensive Care. 2018 May 22;8(1):66. doi: 10.1186/s13613-018-0402-x.

    PubMed 29789983

  • National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

    PubMed 16714767

  • Alhazzani W, Belley-Cote E, Moller MH, Angus DC, Papazian L, Arabi YM, Citerio G, Connolly B, Denehy L, Fox-Robichaud A, Hough CL, Laake JH, Machado FR, Ostermann M, Piraino T, Sharif S, Szczeklik W, Young PJ, Gouskos A, Kiedrowski K, Burns KEA. Neuromuscular blockade in patients with ARDS: a rapid practice guideline. Intensive Care Med. 2020 Nov;46(11):1977-1986. doi: 10.1007/s00134-020-06227-8. Epub 2020 Oct 26.

    PubMed 33104824

  • Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

    PubMed 20843245

  • McAuley DF, Laffey JG, O'Kane CM, Cross M, Perkins GD, Murphy L, McNally C, Crealey G, Stevenson M; HARP-2 investigators; Irish Critical Care Trials Group. Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in acute lung injury to reduce pulmonary dysfunction (HARP-2) trial: study protocol for a randomized controlled trial. Trials. 2012 Sep 17;13:170. doi: 10.1186/1745-6215-13-170.

    PubMed 22985805

  • McAuley DF, Laffey JG, O'Kane CM, Perkins GD, Mullan B, Trinder TJ, Johnston P, Hopkins PA, Johnston AJ, McDowell C, McNally C; HARP-2 Investigators; Irish Critical Care Trials Group. Simvastatin in the acute respiratory distress syndrome. N Engl J Med. 2014 Oct 30;371(18):1695-703. doi: 10.1056/NEJMoa1403285. Epub 2014 Sep 30.

    PubMed 25268516

  • National Heart, Lung, and Blood Institute ARDS Clinical Trials Network; Truwit JD, Bernard GR, Steingrub J, Matthay MA, Liu KD, Albertson TE, Brower RG, Shanholtz C, Rock P, Douglas IS, deBoisblanc BP, Hough CL, Hite RD, Thompson BT. Rosuvastatin for sepsis-associated acute respiratory distress syndrome. N Engl J Med. 2014 Jun 5;370(23):2191-200. doi: 10.1056/NEJMoa1401520. Epub 2014 May 18.

    PubMed 24835849

  • Combes A, Hajage D, Capellier G, Demoule A, Lavoue S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.

    PubMed 29791822

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing protective ventilation, prone position ventilation and glucocorticoid therapy in people with Acute Respiratory Distress Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhaocai Zhang, Doctor (+86-13758131998, 2313003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ventilator-free days (time frame: within 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05658692, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

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