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Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real‐world Data Results from the AlcalUN Study
Author(s) -
Beaume Julie,
Figueres Lucile,
Bobot Mickaël,
Laforcade Louis,
Ayari Hamza,
DolleyHitze Thibault,
Gueutin Victor,
Braconnier Antoine,
Golbin Léonard,
Citarda Salvatore,
Seret Guillaume,
Belaïd Lisa,
Cohen Raphaël,
Luque Yosu,
Larceneux Fabrice,
Seervai Riyad N. H.,
Overs Camille,
Bertocchio JeanPhilippe
Publication year - 2022
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2427
Subject(s) - medicine , sodium bicarbonate , metabolic acidosis , extracellular fluid , acidosis , adverse effect , bicarbonate , prospective cohort study , propensity score matching , nephrology , blood pressure , surgery , extracellular , chemistry , biology , microbiology and biotechnology
Oral alkalization with sodium bicarbonate (NaHCO 3 ) or citrate is prescribed for conditions ranging from metabolic acidosis to nephrolithiasis. Although most nephrologists/urologists use this method routinely, extracellular volume (ECV) increase is the main feared adverse event reported for NaHCO 3 . Thus far, no trial has specifically studied this issue in a real‐world setting. AlcalUN (NCT03035812) is a multicentric, prospective, open‐label cohort study with nationwide (France) enrollment in 18 (public and private) nephrology/urology units. Participants were adult outpatients requiring chronic (>1 month) oral alkalization by either NaHCO 3 ‐containing or no‐NaHCO 3 ‐containing agents. The ECV increase (primary outcome) was judged based on body weight increase (ΔBW), blood pressure increase (ΔBP), and/or new‐onset edema at the first follow‐up visit (V1). From February 2017 to February 2020, 156 patients were enrolled. After a median 106 days of treatment, 91 (72%) patients reached the primary outcome. They had lower systolic (135 (125, 141) vs. 141 (130, 150) , P = 0.02) and diastolic (77 (67, 85) vs. 85 (73, 90), P = 0.03) BP values, a higher plasma chloride (106.0 (105.0, 109.0) vs. 105.0 (102.0, 107.0), P = 0.02) at baseline, and a less frequent history of nephrolithiasis (32 vs. 56%, P = 0.02). Patients experienced mainly slight ΔBP (< 10 mmHg). The primary outcome was not associated ( P = 0.79) with the study treatment (129 received NaHCO 3 and 27 received citrate). We subsequently developed three different models of propensity score matching; each confirmed our results. Chronic oral alkalization with NaHCO 3 is no longer associated with an ECV increase compared to citrate in real‐life settings.