# Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial

> **NIH NIH K23** · BOSTON CHILDREN'S HOSPITAL · 2022 · $54,000

## Abstract

Pediatric in-hospital cardiac arrest is a highly lethal condition with nearly 60% mortality rate, and
survivors are often left with neurologically devastating injuries which persist for a lifetime.
Furthermore, prevention of cardiac arrest is inherent to the NHLBI's mission to “promote the
prevention and treatment of heart, lung, and blood diseases”.
Since pediatric in-hospital cardiac arrest is most commonly preceded by hypotension, its timely
reversal and/or prevention may avert impending cardiac arrest. As a rapid bedside intervention,
the clinical practice of administering bolus dilute epinephrine (BDE) for acute hypotension in the
pediatric intensive care unit has emerged despite scant published evidence to support its use.
As this practice is largely unstudied, optimal dosing of BDE in this population remains unclear.
This project aims to determine if an initial dose of 0.5 mcg/kg versus 1 mcg/kg yields differences
hemodynamic changes with the hypothesis that 1 mcg/kg will offer superior augmentation of
blood pressure. To test this hypothesis, a Phase II, single-center, prospective, randomized,
double-blind, dose-effect trial measuring systolic blood pressure before and after BDE is
proposed. Pediatric patients in the intensive care unit with acute hypotension will be randomized
to receive an initial dose of 0.5 mcg/kg versus 1 mcg/kg of BDE. Changes in systolic blood
pressure following administration of BDE in the two groups will be compared. As a secondary
outcome, the frequency of severe hypertension by age will be assessed. To inform the design of
a future phase III trial, clinical outcomes such as need for subsequent doses, rates of
subsequent cardiac arrest, adverse events and survival to discharge will also be explored. In
addition to the primary clinical trial, a sub-study to develop and evaluate novel methods for
public disclosure under the FDA-regulated Exception From Informed Consent will be performed.
The candidate will pursue formal educational courses in qualitative research, bioethics,
biostatistics and clinical trial design at the Harvard Schools of Medicine and Public Health. At
the end of this training period, the candidate will be poised to meet her career goal of becoming
an independent investigator in the field of pediatric resuscitation. She will have the data to
support a larger trial funded through the R01 mechanism to address the overarching hypothesis
that preemptive treatment of hypotension with a properly titrated dosage of epinephrine will
prevent impending cardiac arrest. Furthermore, the candidate will have the key requisite
experience in conducting future trials through Exception From Informed Consent to address
challenging questions in pediatric resuscitation science that could not otherwise be answered.

## Key facts

- **NIH application ID:** 10690261
- **Project number:** 3K23HL148312-03S1
- **Recipient organization:** BOSTON CHILDREN'S HOSPITAL
- **Principal Investigator:** Catherine Ross
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $54,000
- **Award type:** 3
- **Project period:** 2020-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10690261

## Citation

> US National Institutes of Health, RePORTER application 10690261, Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (3K23HL148312-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10690261. Licensed CC0.

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