Data

SODium BICarbonate for metabolic acidosis in the Intensive Care Unit: A pilot, multicentre, randomized, double-blind clinical trial

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Udy, Andrew A ; Monash University
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ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Adc&rfr_id=info%3Asid%2FANDS&rft_id=info:doi10.26180/28972334&rft.title=SODium BICarbonate for metabolic acidosis in the Intensive Care Unit: A pilot, multicentre, randomized, double-blind clinical trial&rft.identifier=http://doi.org/10.26180/28972334&rft.publisher=Monash University&rft.description=Sodium bicarbonate 8.4% (1000 mEq/L) will be diluted in a 5% dextrose (D5W) solution (500 milliliters bag). For the preparation, 300 mL of D5W will be removed and 300 mL of sodium bicarbonate 8.4% added to prepare the bicarbonate solution in total volume of 500 mL (final concentration: 600 mEq/L).Allocated study drug will be continuously infused targeting a pH > 7.30 and a base excess (BE) > 0 mEq/L. The infusion will be maintained until this target is achieved and continued by titration thereafter for a maximum of 5 hours to maintain target pH and base excess levels.The infusion will start at 100 mL/hr and be kept at this rate until both targets (pH and BE) are achieved. Then, once both targets are achieved it will be decreased to 25 mL/hr and kept constant at this infusion rate until 5 hours after the start of the infusion. After 5 hours of the start of the infusion, the infusion will be stopped independently of the results of the arterial blood gas analysis.Arterial blood gases will be obtained in pre-defined moments within the first 5 hours (at 0, 1 [± 0.1 hours], 3 [± 0.5 hours], and 5 [± 1 hour] hours after the start of the infusion), and then at 12 (± 2 hours), 18 (± 2 hours) and 24 (± 2 hours) hours after the start of the drug infusion. The maximum time of infusion is up to 5 hours after the start of the infusion, until RRT start or ICU discharge, whichever comes first. Open-label sodium bicarbonate infusion is allowed if clinically indicated.&rft.creator=Udy, Andrew A &rft.creator=Monash University &rft.date=2025&rft.relation=https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN12620001361998&rft_rights=Creative Commons Attribution 4.0 International https://creativecommons.org/licenses/by/4.0/legalcode&rft.type=dataset&rft.language=English Access data via landing page

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Sodium bicarbonate 8.4% (1000 mEq/L) will be diluted in a 5% dextrose (D5W) solution (500 milliliters bag). For the preparation, 300 mL of D5W will be removed and 300 mL of sodium bicarbonate 8.4% added to prepare the bicarbonate solution in total volume of 500 mL (final concentration: 600 mEq/L).

Allocated study drug will be continuously infused targeting a pH > 7.30 and a base excess (BE) > 0 mEq/L. The infusion will be maintained until this target is achieved and continued by titration thereafter for a maximum of 5 hours to maintain target pH and base excess levels.

The infusion will start at 100 mL/hr and be kept at this rate until both targets (pH and BE) are achieved. Then, once both targets are achieved it will be decreased to 25 mL/hr and kept constant at this infusion rate until 5 hours after the start of the infusion. After 5 hours of the start of the infusion, the infusion will be stopped independently of the results of the arterial blood gas analysis.

Arterial blood gases will be obtained in pre-defined moments within the first 5 hours (at 0, 1 [± 0.1 hours], 3 [± 0.5 hours], and 5 [± 1 hour] hours after the start of the infusion), and then at 12 (± 2 hours), 18 (± 2 hours) and 24 (± 2 hours) hours after the start of the drug infusion. The maximum time of infusion is up to 5 hours after the start of the infusion, until RRT start or ICU discharge, whichever comes first. Open-label sodium bicarbonate infusion is allowed if clinically indicated.

Notes

HeSANDA 1.0.0

Created: 2025-05-09

Updated: 2025-06-11

Issued: 2025

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Monash University

ROR : https://ror.org/02bfwt286

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