Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) - Catalog
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Name
Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)
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Accession Number
HLB02442123a
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Acronym
PETAL-ROSE
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Related studies
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BSI Study IDs
PTR
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Is public use dataset
False
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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 -
Ingestion StatusReleased
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Has Study Datasets
True
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Has Specimens
True
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Specimen ID TypeCoded
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Study Website
https://petalnet.org/studies.html
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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
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Clinical Trial URLs
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Study typeClinical Trial
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Collection TypeOpen BioLINCC Study
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Cohort typeAdult
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Interventions
Drug: Cisatracurium Besylate
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Study Open Date (Data)
2021-05-10
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Study Open Date (Specimens)
2022-05-06
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Date materials available
2021-05-10
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Last updated
None
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Study period
January 2016 – April 2019
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Study Contacts
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NHLBI Division
DLD
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ClassificationLung
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HIV study classificationnon-HIV
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COVID study classificationnon-COVID
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Pre-Website # of Specimens Shipped
None
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# of Returned Specimens
None
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Primary Publication URLs
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Commercial use data restrictionsNo
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Data restrictions based on area of researchNo
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Commercial use specimen restrictionsNo
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Non-genetic use specimen restrictions based on area of useNo
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Genetic use of specimens allowed?Yes, For Some Specimens
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Genetic use area of research restrictionsYes
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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.
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ConditionsARDS
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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.
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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.
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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.
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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).
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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
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Disease classification
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Publications
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Mat typesDNA
Plasma
Urine
Whole Blood
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NetworkPrevention 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.
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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 <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
Last Modified: April 1, 2024, 10:55 a.m. -
Sex
NMB (intervention) Usual care (control) All Male 291 269 560 Female 210 236 446
Last Modified: April 1, 2024, 10:55 a.m. -
Race
NMB (intervention) Usual care (control) All African American 62 79 141 Missing 63 69 132 Other 16 14 30 White 360 343 703
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.
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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.