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Ideal Steroids for Asthma Treatment in the PICU

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03900624
Acronym
iSTAT PICU
Enrollment
92
Registered
2019-04-03
Start date
2019-04-21
Completion date
2022-05-15
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Childhood

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). Johns Hopkins All Children's Hospital (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.

Interventions

DRUGDexamethasone

Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus

Sponsors

Johns Hopkins All Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Arm Treatment Group with a Prospective, Comparative Cohort Receiving Standard Care

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of StayFrom enrollment through hospital discharge, up to 1 weekHospital length of stay measured in days.

Secondary

MeasureTime frameDescription
Duration of Continuous Nebulized AlbuterolFrom enrollment through hospital discharge, up to 1 weekDuration (in days) of continuous nebulized albuterol.

Other

MeasureTime frameDescription
Number of Participants Receiving an Adjunctive Asthma TherapyFrom enrollment through hospital discharge, up to 1 weekNumber of participants receiving an adjunctive therapy: * use of non-invasive ventilation (NIV) * terbutaline * inhaled helium * inhaled anesthetic gas * mechanical ventilation * extracorporeal life support
Corticosteroid-related Adverse EventsFrom enrollment through hospital discharge, up to 1 weekRates of known corticosteroid-related adverse events including clinically-relevant gastrointestinal bleeding, gastritis, ventilator associated pneumonia, necrotizing enterocolitis, hypertension, hyperglycemia, altered mentation (including hallucinations and delirium), and adrenal insufficiency observed prior to hospital discharge.

Countries

United States

Participant flow

Participants by arm

ArmCount
Methylprednisolone Arm - Standard Care
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
61
Dexamethasone Arm - Interventional Arm
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus. Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
31
Total92

Baseline characteristics

CharacteristicMethylprednisolone Arm - Standard CareDexamethasone Arm - Interventional ArmTotal
Age, Continuous9.7 years
STANDARD_DEVIATION 3.8
9.3 years
STANDARD_DEVIATION 3.5
9.6 years
STANDARD_DEVIATION 3.8
NHLBI Asthma Classification
Intermittent
10 Participants4 Participants14 Participants
NHLBI Asthma Classification
Mild Persistent
13 Participants7 Participants20 Participants
NHLBI Asthma Classification
Moderate Persistent
26 Participants10 Participants36 Participants
NHLBI Asthma Classification
Severe Persistent
12 Participants10 Participants22 Participants
Pediatric Asthma Severity Score11 units on a scale10.5 units on a scale11 units on a scale
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
30 Participants13 Participants43 Participants
Sex: Female, Male
Male
31 Participants18 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 610 / 31
other
Total, other adverse events
12 / 613 / 31
serious
Total, serious adverse events
0 / 610 / 31

Outcome results

Primary

Length of Stay

Hospital length of stay measured in days.

Time frame: From enrollment through hospital discharge, up to 1 week

ArmMeasureValue (MEAN)
Methylprednisolone Arm - Standard CareLength of Stay2.9 days
Dexamethasone Arm - Interventional ArmLength of Stay2.9 days
p-value: 0.632Wilcoxon (Mann-Whitney)
Secondary

Duration of Continuous Nebulized Albuterol

Duration (in days) of continuous nebulized albuterol.

Time frame: From enrollment through hospital discharge, up to 1 week

ArmMeasureValue (MEDIAN)
Methylprednisolone Arm - Standard CareDuration of Continuous Nebulized Albuterol1 days
Dexamethasone Arm - Interventional ArmDuration of Continuous Nebulized Albuterol0.8 days
p-value: 0.725Wilcoxon (Mann-Whitney)
Other Pre-specified

Corticosteroid-related Adverse Events

Rates of known corticosteroid-related adverse events including clinically-relevant gastrointestinal bleeding, gastritis, ventilator associated pneumonia, necrotizing enterocolitis, hypertension, hyperglycemia, altered mentation (including hallucinations and delirium), and adrenal insufficiency observed prior to hospital discharge.

Time frame: From enrollment through hospital discharge, up to 1 week

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsHyperglycemia7 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsGastritis0 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsHypertension1 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsAdrenal insufficiency2 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsAltered mentation2 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsClinically-relevant gastrointestinal bleeding0 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsNecrotizing enterocolitis0 Participants
Methylprednisolone Arm - Standard CareCorticosteroid-related Adverse EventsVentilator associated pneumonia0 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsVentilator associated pneumonia0 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsClinically-relevant gastrointestinal bleeding0 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsAltered mentation0 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsHyperglycemia2 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsNecrotizing enterocolitis0 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsHypertension1 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsGastritis0 Participants
Dexamethasone Arm - Interventional ArmCorticosteroid-related Adverse EventsAdrenal insufficiency0 Participants
Other Pre-specified

Number of Participants Receiving an Adjunctive Asthma Therapy

Number of participants receiving an adjunctive therapy: * use of non-invasive ventilation (NIV) * terbutaline * inhaled helium * inhaled anesthetic gas * mechanical ventilation * extracorporeal life support

Time frame: From enrollment through hospital discharge, up to 1 week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Methylprednisolone Arm - Standard CareNumber of Participants Receiving an Adjunctive Asthma Therapy41 Participants
Dexamethasone Arm - Interventional ArmNumber of Participants Receiving an Adjunctive Asthma Therapy16 Participants
p-value: 0.725Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026