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Ideal Steroids for Asthma Treatment in the PICU (iSTAT PICU)

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ClinicalTrials.gov Identifier: NCT03900624
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony Sochet, Johns Hopkins All Children's Hospital

Brief Summary:
Determine if differences in (1) pediatric intensive care unit length of stay, (2) continuous nebulized albuterol duration, and (3) a composite outcome of advanced asthma therapy incidence including use of non-invasive ventilation (NIV), terbutaline, inhaled helium and mechanical ventilation between cohorts of children admitted with status asthmaticus to the PICU treated with either IV dexamethasone (DM) or methylprednisolone (MP).

Condition or disease Intervention/treatment Phase
Asthma Childhood Drug: Dexamethasone Phase 4

Detailed Description:

As the pathophysiology of an acute asthma exacerbation is dysregulated inflammatory pathways, standard treatment includes the prompt initiation of intravenous systemic corticosteroids. Corticosteroids reduce the production of many mediators involved in the inflammatory process and inhibit macrophages, monocytes, T-lymphocytes, eosinophils, and basophils, which are activated during this process. Furthermore, corticosteroids improve the efficacy of beta-2 agonists, such as albuterol, a nebulized medication used for bronchodilation in acute asthma exacerbations. There remains an ongoing dialogue among the expert medical community regarding the superiority of specific IV corticosteroid, dosing, route and delivery. This debate continues secondary to a lack of definitive comparative data in the literature. While the benefits of receiving systemic corticosteroids has been demonstrated in multiple studies, to date, no head-to-head trials have been conducted comparing IV systemic corticosteroids in the PICU setting (DM vs. MP).

While several systemic corticosteroids are FDA approved for the treatment of asthma exacerbation including prednisone, prednisolone, MP and DM, the standard practice in PICU-level care is IV MP every 6 hours until enteral medications can be safely tolerated. Recent data from emergency room literature would suggest there is equipoise in use of dexamethasone as an alternative for methylprednisolone due to its increased glucocorticoid (anti-inflammatory) potency. Steroid agents are chosen at the discretion of clinical providers based upon a child's capacity to tolerate enteral medications and the specific clinical setting (outpatient vs. general inpatient vs. critical inpatient).

The investigators have performed a retrospective study over a 2-year period to assess if differences in clinical outcomes or adverse events exist in cohorts defined by DM exposure in the ER. Their data revealed no differences, but most children were switched to MP during their PICU stay making data analyses severely confounded by exposure to the defining characteristics of the comparative cohort. The investigators seek to first prospectively consent individuals to receive DM during their PICU asthma treatment and compare outcomes to PICU asthmatics concurrently admitted to the PICU receiving local standard care (MP). JHACH admits approximately 150 asthmatics per year in the PICU and the investigators hope to enroll up to 50 subjects into a DM only arm. The comparative standard care arm will be assessed at the end of the study period. Primary outcomes include (1) PICU Length of Stay, (2) Continuous nebulized albuterol duration, and (3) a composite outcome including use of non-invasive ventilation (NIV), terbutaline, inhaled helium, inhaled anesthetic gas, mechanical ventilation, and extracorporeal life support. This research will provide the needed epidemiologic and basic comparative data required to power and conduct a definitive, head-to-head trial of DM vs. MP.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single Arm Treatment Group with a Prospective, Comparative Cohort Receiving Standard Care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ideal Steroids for Asthma Treatment in the PICU (iSTAT PICU): A Prospective, Comparative, Single-arm Study Assessing Dexamethasone Versus Methylprednisolone in Severe Status Asthmaticus Admitted to the Pediatric Intensive Care Unit
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : May 21, 2020
Estimated Study Completion Date : July 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
No Intervention: Methylprednisolone Arm
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
Experimental: Dexamethasone Arm
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Drug: Dexamethasone
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticu




Primary Outcome Measures :
  1. PICU Length of Stay [ Time Frame: through study completion, approximately 1-year from enrollment ]
    Pediatric intensive care unit length of stay

  2. Duration of continuous nebulized albuterol [ Time Frame: through study completion, approximately 1-year from enrollment ]
    Duration of continuous nebulized albuterol

  3. Composite Outcome of Adjunctive Asthma Therapy [ Time Frame: through study completion, approximately 1-year from enrollment ]
    use of non-invasive ventilation (NIV), terbutaline, inhaled helium, inhaled anesthetic gas, mechanical ventilation, and extracorporeal life support


Secondary Outcome Measures :
  1. Hospital Readmissions [ Time Frame: Within 30 days of hospital discharge ]
    Within 30-day same cause hospital readmission



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria are children 5 to 17 years of age with primary admission diagnoses of acute asthma exacerbation or status asthmaticus admitted to the PICU

Exclusion Criteria:

  • children with existing tracheostomy, cystic fibrosis, and pulmonary hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900624


Locations
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United States, Florida
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
Investigators
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Principal Investigator: Anthony A Sochet, MD, MS Johns Hopkins All Children's Hospital

Publications:

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Responsible Party: Anthony Sochet, Assistant Professor of Anesthesiology and Critical Care Medicine, Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT03900624     History of Changes
Other Study ID Numbers: IRB00187813
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents