Time-critical sepsis interventions and clinical outcomes among children in a tertiary Tanzanian Emergency Department

Résumé fourni par la source

Overview: The primary project is a prospective, observational cohort study of children aged 28 days to 14 years with sepsis at Muhimbili National Hospital, the national referral hospital, in Dar es Salaam, Tanzania (July 2022–November 2024) to determine the risk factors, morbidity, and mortality related to pediatric sepsis in this setting. Children aged 28 days to 14 years who presented with sepsis were included in our study. Sepsis was defined as fever (>38°C or history of fever) with ≥1 World Health Organization danger sign: breathing difficulty, altered mental status, impaired perfusion, or risk of dehydration. Children were excluded for cardiac arrest on arrival, weight <4 kg, acute trauma, non-infectious fever (e.g., rheumatologic disease), isolated seizures in known epilepsy, malignancy, or congenital heart disease. We screened all pediatric patients presenting to the Emergency Department during the study period using consecutive sampling. Parents or guardians of the potential participants were approached by trained research personnel for consent prior to study enrollment. This prospective cohort includes detailed, patient-level clinical, laboratory, microbiologic, treatment, intervention timing, and outcome data collected from emergency department presentation through hospital discharge. Precise timestamps for key sepsis interventions and comprehensive microbiologic testing make the dataset suitable for analyses of sepsis epidemiology, implementation of guideline-based care, prognostic model development, antimicrobial resistance, and evaluation of pediatric sepsis quality improvement interventions in low-resource settings. The submitted repository dataset includes all enrolled participants with de-identified clinical, laboratory, treatment, and outcome data. Objectives: Primary objective: To characterize the delivery and timing of evidence-based sepsis interventions among children presenting with sepsis to a tertiary referral emergency department in Tanzania and evaluate their association with in-hospital mortality. Secondary objectives: To describe the epidemiology, clinical presentation, microbiology, treatments, and hospital outcomes of pediatric sepsis in this resource-limited setting and generate a high-quality prospective dataset to support future studies of pediatric sepsis diagnosis, management, antimicrobial resistance, prognostic models, and implementation research. Data Collection Methods: Once enrolled in the study, participant clinical data, outcomes, and interventions (e.g., antibiotics, mechanical ventilation, blood product transfusions) were extracted from medical records by study staff and entered into REDCap (version 7.2.2), a secure, electronic database. Venous blood was collected in EDTA tubes from all participants within four hours of arrival using sterile technique. Point-of-care tests included rapid diagnostic tests (RDTs) for malaria (SD Bioline-Pf, Abbott Laboratories, Abbott Park, IL, USA) and HIV (Alere Determine HIV-1/2, Abbott Laboratories, Abbott Park, IL, USA), as well as hemoglobin (iSTAT, Abbott Laboratories, Abbott Park, IL, USA) and glucose (GlucoPlus, GlucoPlus Inc., Montreal, Canada). Patients with positive malaria RDT were considered positive. Patients with a positive HIV RDT received subsequent confirmatory testing. Prior to this study, lactate, hemoglobin, and blood glucose were available as point-of-care tests at MNH. Lactate was measured from a whole blood venous sample using an iSTAT system (Abbott Laboratories, Abbott Park, IL, USA). Whole blood was then separated, and plasma was used to measure procalcitonin, C-reactive protein, and ferritin by fluorescence immunoassay using the i-Chroma II system, provided by our study to facilitate real-time measurement (BodiTech Med Inc., Chuncheon-si, Gangwon-do, Republic of Korea). Blood cultures were obtained on all patients using BD BACTEC™ Peds Plus/F vials and processed in a research lab setting using a BD BACTEC FX40 system (Becton Dickinson, Franklin Lakes, New Jersey, USA). All testing followed local protocols and manufacturer instructions. Data Processing Methods: Raw REDCap exports were reviewed for completeness and consistency prior to analysis. Duplicate records were removed, variable labels and coding were standardized, categorical variables were harmonized, and derived variables (including time-to-antibiotics, time-to-intravenous fluids, nutritional status categories, illness severity scores, and outcome variables) were generated using reproducible Stata scripts. Dates and identifiers were removed or transformed to create a fully de-identified dataset prior to repository submission. Analysis datasets were generated directly from the cleaned REDCap export using documented statistical code. All data cleaning, variable coding, and statistical analyses were conducted using Stata/SE 18.0 for Mac (Apple Silicon; StataCorp LLC, College Station, TX; Revision 17 Feb 2026) or SAS 9.4 (SAS Institute, Cary, NC). Stata scripts require one user-contributed package: table1 (available from the SSC archive; install via ssc install table1). All other commands (stset, stcox, sts graph, logit, roctab, roccomp, lincom, estat phtest) are included in the base Stata/SE 18 installation and require no additional packages. Variable definitions are provided in the accompanying REDCap data dictionary, allowing complete reconstruction of analytic variables from the raw dataset. Ethics Declaration: Guardians provided written informed consent; children assented when developmentally and cognitively able; and participants received routine clinical care as indicated, including intravenous fluids, empiric antibiotics, and antimalarial therapy. Children living with Human Immunodeficiency Virus (HIV) continued their antiretroviral medications. The study was approved by the institutional review boards at Muhimbili University of Health and Allied Sciences (DA.282/298/01.C/374), the Tanzanian National Institute for Medical Research (NIMR) (NIMR/HQ/R.8a/Vol. IX/3576), and the University of California, San Francisco (19-27627). Permission to publish was granted by NIMR. The study followed STROBE reporting guidelines. Funding Sources: Research effort to create this publication was supported by the National Institute of Allergy and Infectious Diseases (K23AI144029 [TBK]) of the National Institutes of Health (NIH); the University of California Global Health Institute GloCal/Fogarty Fellowship [D43TW009343] and the University of California, San Francisco T32 Fellowship [5T32HD049303] awarded to Abigail Sorensen.

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