Epinephrine vs Norepinephrine as the Initial Vasoactive Agent in Pediatric Septic Shock: A Feasibility Randomized Controlled Trial for Recruitment Rates and Protocol Adherence, the Epinephrine vs Norepinephrine in Pediatric Septic Shock Trial.
Background and aims: Pediatric guidelines recommend initial resuscitation of septic shock using either epinephrine or norepinephrine as first-line support. However, there are no trials comparing these two agents. The primary aim of this randomized controlled trial was to test the feasibility of a st...
| Publicado en: | Indian Journal of Critical Care Medicine Vol. 29; no. 9; pp. 738 - 747 |
|---|---|
| Autores principales: | , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Jaypee Brothers Medical Publishers Private Limited
Sep2025
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188661690&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188661690 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09725229 SV5 jtl: Indian Journal of Critical Care Medicine issn: 09725229 maglogo: N pubinfo: dt: Sep2025 vid: 29 iid: 9 pid: 50372 pub: Jaypee Brothers Medical Publishers Private Limited artinfo: ui: 188661690 188661690 188661690 10.5005/jp-journals-10071-25043 188661690 ppf: 738 ppct: 9 formats: tig: atl: Epinephrine vs Norepinephrine as the Initial Vasoactive Agent in Pediatric Septic Shock: A Feasibility Randomized Controlled Trial for Recruitment Rates and Protocol Adherence, the Epinephrine vs Norepinephrine in Pediatric Septic Shock Trial. aug: au: Nataraj, Rajeshwari Dalal, Parth Vijayaraghavan, Bharath K. T. Venkatachalam, Priyavarthini Kumar, Vasanth Lakshmanan, Chidambaram Schlapbach, Luregn J. Kissoon, Niranjan Ranjit, Suchitra affil: Department of Paediatric Intensive Care, Apollo Children's Hospital, Chennai, Tamil Nadu, India sug: subj: Shock, Septic Drug Therapy Norepinephrine Therapeutic Use Epinephrine Therapeutic Use Resuscitation Guideline Adherence Research Subject Recruitment Research Protocols Human India Funding Source Randomized Controlled Trials Random Assignment Pilot Studies Double-Blind Studies Descriptive Statistics Intensive Care Units, Pediatric India Exploratory Research Male Female Infant, Newborn Infant Child, Preschool Child Adolescence Data Analysis Software Checklists Adverse Drug Event Infant, Newborn: birth-1 month Infant: 1-23 months Child, Preschool: 2-5 years Child: 6-12 years Adolescent: 13-18 years Male Female ab: Background and aims: Pediatric guidelines recommend initial resuscitation of septic shock using either epinephrine or norepinephrine as first-line support. However, there are no trials comparing these two agents. The primary aim of this randomized controlled trial was to test the feasibility of a study protocol, specifically in terms of recruitment rates and protocol adherence, comparing epinephrine and norepinephrine as first-line vasoactive agents in pediatric septic shock. Patients and methods: A double-blinded, randomized controlled single-center study was conducted in the Emergency Medicine Department (ED) and pediatric intensive care unit (PICU) at a tertiary referral hospital in India. Thirty children aged between 1 month and 17 years with suspected septic shock, in whom signs of shock persisted after the initial fluid bolus, were recruited. Participants were randomized: 1:1 to receive either epinephrine or norepinephrine (each 15), initiated at 0.05-0.1 µg/kg/min. Feasibility outcomes were recruitment rates, randomization to study-drug initiation time, and adherence to protocol. Exploratory clinical outcomes included proportion of shock resolution, adverse events, and hospital mortality. Results: Of 44 screened patients, 10 met exclusion criteria and 4 declined consents, with a recruitment rate of 3.2 patients/month. The median time to vasoactive initiation after randomization was 12 minutes (IQR 8-15). The median time for shock resolution was 31 hours (IQR 10.8-51.2) and 14 hours (IQR 11.5-16.5) in the epinephrine and norepinephrine groups, respectively. Adverse events meeting pre-determined stopping criteria occurred in 7/16 and 1/15 in the epinephrine and norepinephrine groups, respectively. One patient in each group died. Conclusions: A protocol randomizing children with septic shock to epinephrine vs norepinephrine was feasible in terms of protocol adherence and recruitment rates. These findings can inform the design of a definitive multicenter trial powered for patient-centered endpoints. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|