Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) - Catalog

Name

Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)

Accession Number

HLB02442123a

Acronym

PETAL-ROSE

Related studies

BSI Study IDs

PTR

Is public use dataset

False

Keywords

Acute Lung Injury

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Infant, Premature, Diseases

Infant, Newborn, Diseases

Lung Injury

Neuromuscular Blocking Agents

Peripheral Nervous System Agents

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

https://petalnet.org/studies.html

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Study type

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Drug: Cisatracurium Besylate

Study Open Date (Data)

2021-05-10

Study Open Date (Specimens)

2022-05-06

Date materials available

2021-05-10

Last updated

None

Study period

January 2016 – April 2019

Study Contacts
NHLBI Division

DLD

Classification

Lung

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

None

# of Returned Specimens

None

Conditions

ARDS

Objectives

To determine the efficacy and safety of early neuromuscular blockade with concomitant heavy sedation as compared with a strategy of usual care with lighter sedation targets in patients with moderate-to-severe ARDS.

Background

It has been well established that the approaches used for the application of mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) can affect survival and outcomes after discharge from the intensive care unit (ICU). A large, multicenter trial conducted a decade before this study reported that the early administration of a 48-hour infusion of neuromuscular blockade in patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen [Pao2] to the fraction of inspired oxygen [Fio2] of <150 mm Hg with a positive end-expiratory pressure [PEEP] of ≥5 cm of water) resulted in lower mortality than a strategy of deep sedation without routine neuromuscular blockade. Despite these encouraging results, early neuromuscular blockade has not been widely adopted. Potential concerns include the lack of research comparing neuromuscular blockade and deep sedation with current practice (which promotes lighter sedation targets) as well as limited data on the effect of neuromuscular blockade on neuromuscular function and other long-term outcomes. Therefore, the PETAL-ROSE study was initiated to determine the efficacy and safety of early neuromuscular blockade with concomitant heavy sedation as compared with a strategy of usual care with lighter sedation targets.

Participants

Eligible participants were adults undergoing mechanical ventilation through an endotracheal tube and who had the presence of all the following conditions for less than 48 hours: PaO2/FiO2 < 150 mm Hg with a PEEP of ≥ 8 cm of water, bilateral pulmonary opacities not explained by effusions or lung collapse, and respiratory failure not explained by cardiac failure or fluid overload.


1006 participants were enrolled. 501 participants were randomly assigned to the intervention group, and 505 participants were randomly assigned to the control group.

Design

PETAL-ROSE was a multicenter, unblinded, randomized trial of patients with moderate-to-severe ARDS. Participants were randomly assigned in a 1:1 ratio to receive 48 hours of continuous neuromuscular blockade with concomitant deep sedation (intervention group) or to receive usual care without routine neuromuscular blockade and with lighter sedation targets (control group).


Patients in the intervention group who were not under deep sedation at baseline were deeply sedated within 4 hours after randomization. Subsequently, patients in this group received an intravenous bolus of 15 mg of cisatracurium, followed by a continuous infusion of 37.5 mg per hour for 48 hours. After the 48-hour trial intervention period, decisions regarding further use of neuromuscular blockade, including the choice of agent, were left to the discretion of the treating clinician. Neuromuscular blockade could be stopped early if the patient met the criteria for freedom from mechanical ventilation (Fio2 ≤0.40 and PEEP ≤8 cm of water) for at least 12 hours.


All patients were treated with a strategy of low tidal volume ventilation within 2 hours after randomization and a high PEEP strategy for up to 5 days after randomization. Assessors who were unaware of the group assignment interviewed surviving patients or their proxies at 3, 6, and 12 months after randomization.


The primary end point was in-hospital death from any cause at 90 days (in-hospital was defined as the time in the trial hospital plus transfer to another hospital, including the time in long-term acute care facilities).

Conclusions

After the second interim analysis, the decision to stop the trial for futility was made independently by the data and safety monitoring board.


In critically ill patients identified shortly after the diagnosis of moderate-to-severe ARDS, the addition of early continuous neuromuscular blockade with concomitant deep sedation did not result in lower mortality than a usual-care approach to mechanical ventilation that included lighter sedation targets.


National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Moss M, Huang DT, et al. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019;380(21):1997-2008. doi:10.1056/NEJMoa1901686

Disease classification

Publications

Mat types

DNA
Plasma
Urine
Whole Blood

Network

Prevention and Early Treatment of Acute Lung Injury (PETAL)

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    1006 subjects (501 NMB (intervention, 505 Usual care (control))


    Last Modified: July 22, 2022, 1:50 p.m.
  • Age
     NMB (intervention)Usual care (control)All
    <30214263
    30-395053103
    40-497372145
    50-59129123252
    60-69137118255
    70-797171142
    80-89202646

    Last Modified: April 1, 2024, 10:55 a.m.
  • Sex
     NMB (intervention)Usual care (control)All
    Male291269560
    Female210236446

    Last Modified: April 1, 2024, 10:55 a.m.
  • Race
     NMB (intervention)Usual care (control)All
    African American6279141
    Missing6369132
    Other161430
    White360343703

    Last Modified: April 1, 2024, 10:55 a.m.

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types

    Plasma, Whole blood, Urine


    Last Modified: July 22, 2022, 1:50 p.m.
  • General Freeze/Thaw Status

    All samples have 0 thaws


    Last Modified: July 22, 2022, 1:50 p.m.
  • Visits (Vials)

    04/01/2024

     

    Plasma

    Whole Blood

    DNA

    Urine

    Total

    Day 0

    4604

    8944

    3183

    2582

    19313

    Day 1

    3442

    .

    .

    2373

    5815

    Day 2

    4993

    1662

    77

    2264

    8996


    Last Modified: April 1, 2024, 10:54 a.m.
  • Visits (Subjects)

    04/01/2024

     

    Plasma

    Total number of subjects

    Average volume (ml) per subject

    Day 0

    957

    3.24

    Day 1

    912

    4.54

    Day 2

    866

    4.32

     

     

    Whole Blood

    Total number of subjects

    Average volume (ml) per subject

    Day 0

    902

    9.06

    Day 2

    815

    9.10

     

     

    DNA

    Total number of subjects

    Average mass (ug) per subject

    Day 0

    885

    9.07

    Day 2

    21

    9.60

     

     

    Urine

    Total number of subjects

    Average volume (ml) per subject

    Day 0

    867

    5.12

    Day 1

    796

    5.17

    Day 2

    757

    5.17


    Last Modified: April 1, 2024, 10:53 a.m.