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  • Sodium bicarbonate for the treatment of severe metabolic acidosis with moderate or severe acute kidney injury in the critically ill: protocol for a randomised clinical trial (BICARICU-2)

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Intensive care
Protocol
Sodium bicarbonate for the treatment of severe metabolic acidosis with moderate or severe acute kidney injury in the critically ill: protocol for a randomised clinical trial (BICARICU-2)
  1. Boris Jung1,2,
  2. Helena Huguet3,
  3. Nicolas Molinari3,
  4. Samir Jaber2,4
  1. 1Department of Medical Intensive Care, Montpellier University Hospital, Montpellier, France
  2. 2PhyMedExp Laboratory, University of Montpellier, Montpellier, France
  3. 3Department of Statistics, Montpellier Université d’Excellence, Montpellier, France
  4. 4Saint Eloi Department of Anesthesiology and Critical Care Medicine, Montpellier University Hospital, Montpellier, France
  1. Correspondence to Professor Boris Jung; b-jung{at}chu-montpellier.fr

Abstract

Introduction When both severe metabolic acidemia (pH equal or less than 7.20; PaCO2 equal or less than 45 mm Hg and bicarbonate concentration equal or less than of 20 mmol/L) and moderate-to-severe acute kidney injury are observed, day 28 mortality is approximately 55%–60%. A multiple centre randomised clinical trial (BICARICU-1) has suggested that sodium bicarbonate infusion titrated to maintain the pH equal or more than 7.30 is associated with a higher survival rate (secondary endpoint) in a prespecified stratum of patients with both severe metabolic acidemia and acute kidney injury patients. Whether sodium bicarbonate infusion may improve survival at day 90 (primary outcome) in these severe acute kidney injury patients is currently unknown.

Methods and analysis The sodium bicarbonate for the treatment of severe metabolic acidosis with moderate or severe acute kidney injury in the critically ill: a randomised clinical trial (BICARICU-2) trial is an investigator-initiated, multiple centre, stratified, parallel-group, unblinded trial with a computer-generated allocation sequence and an electronic system-based randomisation. After randomisation, the intervention group will receive 4.2% sodium bicarbonate infusion to target a plasma pH equal or more than 7.30 while the control group will not receive sodium bicarbonate. The primary outcome is the day 90 mortality. Main secondary outcomes are organ support dependences.

Ethics and dissemination The trial has been approved by the appropriate ethics committee (CPP Nord Ouest, Rouen, France, 25 April 2019, number: 19.03.15.72446). Informed consent is required. If sodium bicarbonate improves day 90 mortality, it will become part of the routine care.

Trial registration number NCT04010630.

  • INTENSIVE & CRITICAL CARE
  • Adult intensive & critical care
  • Clinical Trial
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2023-073487

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    Footnotes

    • Twitter @borisjung34

    • Contributors BJ drafted the manuscript. BJ designed the trial together with SJ. HH and NM wrote the statistical analysis plan and estimated the sample size. All authors revised the manuscript for important intellectual content and read and approved the final version of the manuscript.

    • Funding The trial is an investigator-initiated trial. The promoter is Montpellier University Hospital, Montpellier, France. The trial was funded by the National Ministry of Health, France (PHRC-N 2018-000671-16).

    • Competing interests SJ reports receiving consulting fees from Drager, Medtronic, Mindray, Baxter, Fisher & Paykel and Fresenius-Xenios. No potential conflict of interest relevant to this article was reported for other authors.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.