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

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Accession Number

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
January 2016 – April 2019

NHLBI Division

Dataset(s) Last Updated
May 17, 2022


Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Commercial Use Specimen Restrictions No

Non-Genetic Use Specimen Restrictions Based On Area Of Use No

Genetic Use Of Specimens Allowed? Yes, For Some Specimens

Genetic Use Area Of Research Restrictions Yes

Specific Consent Restrictions
Use of specimens in non-genetic research is unrestricted. Use of specimens in genetic research is tiered to 1) future research in ARDS and 2) future research related to other medical conditions.


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.


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.


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.


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).


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

Additional Details


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

  NMB (intervention) Usual care (control) All
<30 21 42 63
30-39 50 53 103
40-49 73 72 145
50-59 129 123 252
60-69 137 118 255
70-79 71 71 142
80-89 20 26 46
  NMB (intervention) Usual care (control) All
Male 291 269 560
Female 210 236 446
  NMB (intervention) Usual care (control) All
African American 62 79 141
Missing 63 69 132
Other 16 14 30
White 360 343 703

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 of the BioLINCC handbook describes the components of the review process

Material Types:

Plasma, Whole blood, Urine

General Freeze/Thaw Status:

All samples have 0 thaws

Visits (Vials):
  Plasma Whole Blood DNA Urine Total
Day 0 4595 8944 3183 2582 19304
Day 1 3457 . . 2373 5830
Day 2 4916 1662 77 2264 8919
Visits (Subjects):
Total number of subjects Average volume (ml) per subject
Day 0 957 3.25
Day 1 912 4.57
Day 2 866 4.42
  Whole Blood
Total number of subjects Average volume (ml) per subject
Day 0 902 9.06
Day 2 815 9.10
Total number of subjects Average mass (ug) per subject
Day 0 885 9.07
Day 2 21 9.60
Total number of subjects Average volume (ml) per subject
Day 0 867 5.12
Day 1 796 5.17
Day 2 757 5.17

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Resources Available

Specimens and Study Datasets

Materials Available

Study Documents

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