Sodium Bicarbonate for Severe Metabolic Acidemia and Acute Kidney Injury
Boris Jung, Matthieu Jabaudon, Audrey De Jong, Laurent Bitker, Jules Audard, Kada Klouche, Benjamine Sarton, Christophe Guitton, Sigismond Lasocki, Benjamin Rieu, Emmanuel Canet, Caroline Jeantrelle, Antoine Roquilly, Julien Mayaux, Franck Verdonk, Julien Pottecher, Martine Ferrandière, Béatrice Riu, Pierre Garçon, Mona Assefi, Philippe Detouche, Jean Marie Forel, Claire Roger, Jérémy Bourenne, Sophie Jacquier, David Bougon, Amélie Rollé, P. Corne, Nacim Benchabane, Jean‐Christophe Richard, Karim Asehnoune, Gérald Chanques, Jean Reignier, Foud Belafia, Maxime Fosset, Hélèna Huguet, Emmanuel Futier, Nicolas Molinari, Samir Jaber, BICARICU-2 Study Group, Sónia Machado, Vincent Brunot, Laura Platon, Delphine Daubin, Noémie Besnard, V. Moulaire, Corinne Pellé, Liliane Landreau, Guillaume Deneil, Hodane Yonis, Mehdi Mezidi, Louis Chauvelot, Stein Silva, Patrice Tirot, Cédric Darreau, Nicolas Chudeau, Maëva Campfort, Soizic Gergaud, Loris Giordanetto, Thomas Godet, Jean Baptiste Lascarrou, Jean Reignier, Mikhaël Giabicani, Karim Ashenoune, Yannick Hourmant, Alexre Bourdiol, Cécile Poulain, Alexre Demoule, Martin Dres, Maxens Decavèle, Marie Lecronier, Côme Bureau, Julien Do Vale, Sophie Menat, Sébastien Clerc, Jérémie Pichon, Jennifer Catano, Adam Celier, Valentine Le Stang, Marie-Claire Diemoz, Hugo Flis-Richard, Emmanuel Pardo, Natacha Kapandji, Alain Meyer, Stephane Hecketsweiler, Paer Abback, Ly Van Vong, Delphine Reitter, Jonathan Zarka, Jean Michel Constantin, Florence Daviet, Laurent Müller, Jean Yves Lefrant, Stéphan Ehrmann, Charlotte Salmon Ginniere, Laetitia Contentin, Julien Carvelli, Marc Gainier, Bernard Cholley, Jean Dellamonica
Abstract
Importance: The effect of sodium bicarbonate infusion on outcome in patients with severe metabolic acidemia and moderate to severe acute kidney injury is unknown. Objective: To determine whether sodium bicarbonate infusion is associated with day 90 all-cause mortality in patients with severe metabolic acidemia and moderate to severe acute kidney injury. Design, Setting, and Participants: Randomized, open-label, clinical trial conducted with 640 patients in 43 French intensive care units from October 6, 2019, to December 19, 2023, with 90-day follow-up. The last date of follow-up was June 17, 2024. Adults with severe metabolic acidemia (defined as pH ≤7.20) and moderate to severe acute kidney injury were enrolled. Intervention: Patients were randomized 1:1 to receive either intravenous sodium bicarbonate infusion or no sodium bicarbonate to target an arterial pH of 7.30 or higher. Main Outcomes and Measures: The primary outcome was day 90 all-cause mortality. Secondary outcomes included day 28 and day 180 all-cause mortality; use of organ support therapy, vasopressors, or invasive mechanical ventilation; intensive care unit and hospital length of stay; intensive care unit-acquired infections; fluid balance; day-7 Sequential [Sepsis-related] Organ Failure Assessment score (6 organ systems' function is evaluated and scored from 0 [no dysfunction] to 4 [failure]; total score ranges from 0 [normal] to 24 [maximum failure]); and major adverse kidney events on day 90. Results: Among 640 randomly assigned patients, 627 were analyzed (313 in the control group and 314 in the bicarbonate group). The median age was 67 years (IQR, 59-74 years); 194 of 314 patients (62%) in the bicarbonate group and 185 of 313 controls (59%) were male. In the primary analysis, day 90 all-cause mortality was 195 of 314 patients (62.1%) in the bicarbonate group and 193 of 313 (61.7%) in the control group (absolute difference, 0.4; 95% CI, -7.2 to 8.0; P = .91). There was no evidence of a group effect on day 28 or day 180 all-cause mortality. Among 18 secondary outcomes, kidney replacement therapy was used in 109 of 314 (35%) bicarbonate group patients and 157 of 313 (50%) controls (absolute difference, -15.5; 95% CI, -23.1 to -7.8). No evidence of a group effect was found on other secondary outcomes, including adverse events. Conclusions and Relevance: For patients with severe metabolic acidemia and moderate to severe acute kidney injury, intravenous sodium bicarbonate did not affect mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT04010630.