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Public studies

Primary study

  • ROSE: Reevaluation Of Systemic Early neuromuscular blockade

    Status:
    Active
    Period:
    January 2016 to December 2018
    NCT ID:
    NCT02509078

    Purpose: This study is evaluating whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged .

    Trial Summary: Study Design: This is a multi-center, prospective, 2-arm, unblinded, randomized clinical trial of two management strategies of neuromuscular blockade (also called skeletal muscle relaxant and muscle relaxant). Purpose: To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS in comparison to a control group with no routine early neuromuscular blockade. Sample Size: This trial will enroll approximately 1400 subjects from PETAL network hospital ICUs.

  • VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment

    Status:
    Pending
    Period:
    April 2017
    NCT ID:
    (pending)

    Purpose: This study will look at the effect of early administration of high-dose vitamin D3 in reducing mortality in patients with low levels of vitamin D who are at high risk for Acute Respiratory Distress Syndrome (ARDS). Patients will be screened for vitamin D deficiency (levels less than 20 ng/mL). Those patients meeting the screening threshold will be randomized into the trial. Half of the vitamin-D deficient patients will be given a high-dose of vitamin D3 and the other half will be given a placebo (like a sugar pill).

    Trial Summary: Study Design: Randomized, double-blinded, placebo-controlled, phase III trial of early vitamin D3 in vitamin D deficient patients at high risk for ARDS and mortality. Purpose: To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for ARDS and mortality. Sample Size: The study will randomize up to 3,000 patients from PETAL network hospital emergency departments, ICUs, and general floors.

Ancillary study

  • PRIMROSE: Effect of randomization to neuromuscular blockade on physical functional impairment and recovery in ARDS

    Status:
    Active
    Period:
    June 2016 to May 2020
    NCT ID:
    NCT03038906

    Multi-center prospective cohort study using stage-appropriate multi-modal assessments of neuromuscular function to determine the effect of randomization to neuromuscular blockers (NMB) in the ROSE trial. The study will assess effect of NMB on the early development of neuromyopathy; on muscle function and strength at hospital discharge; and on physical recovery and healthcare utilization at 6 and 12 months after the development of severe ARDS.

  • RED ROSE (Reconciling Expected vs Delivered Tidal Volumes in ROSE with Patient-ventilator Dyssynchrony)

    Status:
    Active
    Period:
    December 2016 to May 2020
    NCT ID:

    Multi-center prospective observational study ancillary to the PETAL Network ROSE trial. The purpose of this study is to evaluate a proposed mechanism of benefit for neuromuscular blockers in the treatment of ARDS: occult high-VT breaths
    during low tidal volume ventilation.

  • Provider perceptions of neuromuscular blockade in ARDS (PETE ROSE)

    Status:
    Active
    Period:
    March 2017 to April 2020
    NCT ID:

    Observational study to understand bedside provider perceptions of neuromuscular blocker use in ARDS using interview tools. Interviews will be conducted with physicians, nurses, clinical pharmacists, and respiratory therapists providing direct care to patients in the intervention arm of ROSE, as well as physicians who have declined enrollment of their patients into the ROSE trial.

  • Re-Evaluation of Systemic Early Neuromuscular Blockade and TransThoracic Ultrasound Assessment of the Diaphragm (ROSETTA)

    Status:
    Pending
    Period:
    May 2017
    NCT ID:

    Diaphragm thickness will be measured using ultrasound in a subset of ROSE patients to determine whether the rate and magnitude of decreases in diaphragm thickness are greater in patients receiving neuromuscular blocking agents as compared to the control group.

  • ROSE-Transthoracic Ultrasound Assessment of the Diaphragm (ROSETTA)

    Status:
    Pending
    Period:
    June 2017
    NCT ID:

    An observational trial involving a subset of subjects from the ROSE neuromuscular blocker trial. The study involves diaphramatic ultrasound on mechanically ventilated ROSE subjects to determine whether the rate and magnitude of decreases in diaphragm thickness are greater in patients receiving neuromuscular blocking agents.