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Additional Bicarbonate Infusion Complements WHO Rehydration Therapy in Children with Acute Diarrhea and Severe Dehydration Presenting with Severe Non-anion Gap Metabolic Acidemia: An Open Label Randomized Trial

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Indian Journal of Pediatrics Aims and scope Submit manuscript

Abstract

Objectives

To assess the efficacy and safety of bicarbonate infusion in children with Acute Diarrhea and Severe Dehydration (ADSD) having severe Non-Anion Gap Metabolic Acidemia (sNAGMA).

Methods

Children (aged 1–144 mo) with ADSD and sNAGMA (pH ≤7.2 and/or serum bicarbonate ≤15 mEq/L) were enrolled in an open-label randomized design. Controls (n = 25) received WHO-recommended rehydration therapy with Ringer Lactate, while intervention group (n = 25) received additional bicarbonate deficit correction. Primary outcome was time taken to resolve metabolic acidemia (pH >7.30 and/or bicarbonate >15 mEq/L). Secondary outcome measures were adverse outcome [composite of pediatric intensive care unit (PICU) transfer and deaths], acute care area free days in 5 d (ACAFD5), hospital stay, and adverse effects.

Results

Time taken to resolve metabolic acidemia was significantly lesser with intervention [median (IQR); 8 h (4, 12) vs. 12 h (8, 24); p = 0.0067]. Intervention led to acidemia resolution in significantly more children by 8 h and 16 h (17/25 vs. 9/25, p = 0.035 and 23/25 vs. 17/24, p = 0.018, respectively). Patients with fluid refractory shock needed lesser inotropes in intervention group [median Vasoactive Inotrope Score (VIS), 10.5 vs. 34]. Intervention led to significantly lesser adverse outcome (0/25 vs. 5/25, p = 0.049), and noticeably more ACAFD5 [median (IQR); 2 (1, 2) vs. 1 (1, 2); p = 0.12]. Two patients died in the control group while none in the intervention group. No adverse effect was documented.

Conclusions

Additional calculated dose of bicarbonate infusion led to significantly early resolution of metabolic acidemia, lesser utilization of critical care facilities, and lesser adverse outcome in children with ADSD and sNAGMA, compared to standard therapy, with no adverse effect.

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Authors and Affiliations

Authors

Contributions

LT enrolled the patients, executed the study protocol, did literature search, statistical analysis and prepared first draft of the manuscript. AKB reviewed the literature, conceptualised, planned and developed the study design, supervised conduct of the study, did statistical analysis, and prepared final draft of the manuscript. PKG participated in development of the study design, guided statistical analysis, and reviewed the final draft. SKA participated in development of the study design. MJ critically reviewed final draft of the manuscript. AKB will act as guarantor for this manuscript.

Corresponding author

Correspondence to Arun K. Baranwal.

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12098_2023_4925_MOESM1_ESM.docx

Supplementary Fig. S1 Study flow diagram. ADSD Acute diarrhea and severe dehydration, IEM Inborn errors of metabolism (DOCX 27.9 KB)

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Takia, L., Baranwal, A.K., Gupta, P.K. et al. Additional Bicarbonate Infusion Complements WHO Rehydration Therapy in Children with Acute Diarrhea and Severe Dehydration Presenting with Severe Non-anion Gap Metabolic Acidemia: An Open Label Randomized Trial. Indian J Pediatr (2023). https://doi.org/10.1007/s12098-023-04925-x

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