Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real‐world Data Results from the AlcalUN Study. Issue 1 (11th October 2021)

• Record Type: Journal Article
• Authors: Beaume, Julie; Figueres, Lucile; Bobot, Mickaël; de Laforcade, Louis; Ayari, Hamza; Dolley‐Hitze, 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, Jean‐Philippe
• Is Part Of: Clinical pharmacology & therapeutics. Volume 111:Issue 1(2022)
• Page Start: 252
• Page End: 262
• Publication Date: 2021-10-11
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.2427
• Languages: English
• ISSNs: 0009-9236

Abstract

Abstract : Oral alkalization with sodium bicarbonate (NaHCO3 ) 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 NaHCO3 . 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 NaHCO3 ‐containing or no‐NaHCO3 ‐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 NaHCO3 and 27 received citrate). We subsequently developed three different models of propensity score matching; each confirmed our results. Chronic oral alkalization with NaHCO3 is no longer associated with an ECV increase compared to citrate in real‐life settings.