Stress Hydrocortisone in Pediatric Septic Shock: Protocol for a Pragmatic, Multicenter, International, Randomized, Double-Blinded, Placebo-Controlled Interventional Trial
Bibliographic record
Abstract
OBJECTIVES: Septic shock accounts for approximately 8% of PICU admissions worldwide, carries significant morbidity, and has a reported mortality rate between 5% and 50% depending upon the geographic region in which it occurs. The high morbidity and mortality of this condition have led clinicians to consider corticosteroids when usual management does not achieve hemodynamic stability. However, the evidence for or against the use of corticosteroids in pediatric septic shock is currently unclear. DESIGN: Pragmatic, multicenter, international, randomized, double-blinded, placebo-controlled interventional trial (ClinicalTrials.gov, NCT03401398). SETTING: Approximately 50 PICUs from 11 countries in North America, South America and Asia. PATIENTS: Up to 500 eligible pediatric patients aged one month to 17 years and 8 months with septic shock. INTERVENTIONS: Patients randomized to the hydrocortisone arm receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg every six hours until all vasoactive-inotropic infusions have been discontinued for at least 12 h or for a maximum of 7 days. Patients randomized to the placebo arm receive an equivalent volume of normal saline with the identical dosing schedule. MEASUREMENTS AND MAIN RESULTS: The primary outcome is the frequency of new or progressive multiple-organ dysfunction syndrome up to 28 days following enrollment, death or discharge, whichever comes first. The secondary outcome is a composite of the frequency of death or greater than or equal to 25% decrease in health-related quality of life from baseline, assessed at 28 days. CONCLUSIONS: The current Pediatric Surviving Sepsis Guidelines do not provide definitive recommendations regarding the use of corticosteroids in pediatric septic shock. Our study will be the first pediatric trial that is adequately powered to assess both potential benefits and adverse effects of corticosteroids in patients with septic shock. The results of this study will provide definitive data upon which to base future recommendations for corticosteroid administration in pediatric septic shock.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.030 | 0.030 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.006 | 0.007 |
| Insufficient payload (model declined to judge) | 0.056 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".