Drugs / Sodium Lactate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) LACTATED RINGER'S IN PLASTIC CONTAINER 1971-03-22 fda.gov

Trials 10 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 24 trials
Phase 2 NCT05004610 Feb 2025 → Dec 2027 expected brain injury, cardiac arrest, ischemic disease Erasme University Hospital Recruiting No outcome recorded
Phase 2 NCT06634069 Nov 2024 → Oct 2027 expected infectious disease with sepsis, intracranial hypertension University Hospital Pilsen Recruiting No outcome recorded
Phase 2 NCT02776488 Sep 2020 → Dec 2025 traumatic brain injury University of California, Los Angeles Withdrawn No outcome recorded
Phase 2 NCT01981655 Dec 2009 → Feb 2013 heart failure Nepean Blue Mountains Local Health District Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT03528213 Oct 2019 → Feb 2023 infectious disease with sepsis University Hospital, Lille Completed No outcome recorded
Phase 2/3 NCT00995683 Jun 2009 → May 2011 traumatic brain injury Institut d'Anesthesiologie des Alpes Maritimes Completed No outcome recorded
Phase 2/3 NCT00319345 Nov 2003 → Nov 2005 intracranial hypertension, traumatic brain injury Institut d'Anesthesiologie des Alpes Maritimes Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT04488874 Sep 2020 → May 2023 intracranial hypertension Centre Hospitalier Universitaire de Besancon Completed No outcome recorded
Phase not applicable2 trials
NCT03286816 Nov 2016 → May 2017 type 1 diabetes mellitus Radboud University Medical Center Completed No outcome recorded
NCT01455376 Mar → Jun 2010 traumatic brain injury Padjadjaran University Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT06701760 Comparator Jan 2028 → Dec 2035 expected traumatic brain injury University of California, Los Angeles Not yet recruiting No outcome recorded
Phase not applicable2 trials
NCT04710875 Comparator Mar → Jun 2021 lactic acidosis University of Aarhus Completed No outcome recorded
NCT04299815 Comparator Apr → Jul 2020 lactic acidosis University of Aarhus Completed No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as Sodium Lactate ClinicalTrials.gov intervention name — accepted as the source's own label NCT04299815
11

NCT00319345

NCT04488874

NCT01455376

NCT02776488

NCT05004610

NCT00995683

NCT03528213

NCT06634069

NCT01981655

NCT03286816

NCT06701760

Known as HSL “The aim of this study was to assess the clinical effectiveness of intravenous hypertonic sodium lactate (HSL) for intra-operative brain relaxation in supratentorial brain...” PMID 42109031 May 2026
Known as LAC “half-molar lactate (LAC)” PMID 39825426 Jan 2025
Known as Na-lactate ClinicalTrials.gov intervention name — accepted as the source's own label NCT04710875
Modality Other / unclassified “a newly designed crystalloid solution, 0.5 M sodium lactate” NCT01981655
Route Intravenous intravenous infusion” NCT01455376