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Trial record 2 of 117 for:    ideal icu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900624
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2019
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins All Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date September 10, 2021
Actual Study Start Date  ICMJE May 21, 2019
Estimated Primary Completion Date May 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • PICU Length of Stay [ Time Frame: through study completion, approximately 1-year from enrollment ]
    Pediatric intensive care unit length of stay
  • Duration of continuous nebulized albuterol [ Time Frame: through study completion, approximately 1-year from enrollment ]
    Duration of continuous nebulized albuterol
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Hospital Readmissions [ Time Frame: Within 30 days of hospital discharge ]
Within 30-day same cause hospital readmission
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ideal Steroids for Asthma Treatment in the PICU
Official Title  ICMJE 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
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Asthma Childhood
Intervention  ICMJE Drug: Dexamethasone
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticu
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Dexamethasone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 21, 2022
Estimated Primary Completion Date May 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03900624
Other Study ID Numbers  ICMJE IRB00187813
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins All Children's Hospital
Study Sponsor  ICMJE Johns Hopkins All Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony A Sochet, MD, MS Johns Hopkins All Children's Hospital
PRS Account Johns Hopkins All Children's Hospital
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP