Sodium Lactate in Severe TBI

NCT06701760 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-011590
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a safety phase 2 clinical trial of intravenous infusion of sodium lactate in patients with severe TBI. This study is intended for patients in the acute setting in an intensive care unit at centers that have been selected to participate in this trial. This is a proof of safety study and biomarker response study.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; coma; intensive care; brain metabolism

Outcome Measures

Primary Outcomes (2)

• mortality

  Mortality

  30 days

• Dose limiting toxicity

  panel of serious adverse events

  7 days

Study Arms (2)

intervention

ACTIVE COMPARATOR

sodium lactate

Drug: Sodium Lactate

placebo

PLACEBO COMPARATOR

sodium cbloride infusion

Drug: placebo

Interventions

Sodium Lactate DRUG

sodium lactate

intervention

placebo DRUG

infusion of sodium chloride

Also known as: sodium chloride

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GCS at enrollment 3-8
• Male or female aged 18-80 at admission
• acute positive CT findings
• ability for subject to comply with the requirements of the study
• written informed consent obtained from subject or subject's legal representative.

You may not qualify if:

• Penetrating TBI
• History of neurological disease, including Parkinson's, Huntington's, Alzheimer's, etc.
• History of diabetes mellitus
• Serum sodium ≥ 148 mM
• Metabolic acidosis pH \<7.34
• Coagulopathy INR \> 1.3, platelets \< 100,000, or hematocrit \< 28 mg/dl
• Renal insufficiency with GFR \< 60% of expected or Cr \> 1.3;
• AST or ALT \> 1.5x upper limit of normal; Severe liver trauma;
• baseline serum lactate \> 2 mM
• Hypotension SBP \< 90 refractory to vasopressors
• Known mitochondrial genetic disorder
• Pregnancy
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• Member of a protected population; simultaneous participation in another randomized trial

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (4)

• Bernini A, Miroz JP, Abed-Maillard S, Favre E, Iaquaniello C, Ben-Hamouda N, Oddo M. Hypertonic lactate for the treatment of intracranial hypertension in patients with acute brain injury. Sci Rep. 2022 Feb 22;12(1):3035. doi: 10.1038/s41598-022-07129-z.

  PMID: 35194150 RESULT

• Wolahan SM, Mao HC, Real C, Vespa PM, Glenn TC. Lactate supplementation in severe traumatic brain injured adults by primed constant infusion of sodium L-lactate. J Neurosci Res. 2018 Apr;96(4):688-695. doi: 10.1002/jnr.24085. Epub 2017 May 20.

  PMID: 28543565 RESULT

• Glenn TC, Martin NA, Horning MA, McArthur DL, Hovda DA, Vespa P, Brooks GA. Lactate: brain fuel in human traumatic brain injury: a comparison with normal healthy control subjects. J Neurotrauma. 2015 Jun 1;32(11):820-32. doi: 10.1089/neu.2014.3483. Epub 2015 Mar 31.

  PMID: 25594628 RESULT

• Glenn TC, Kelly DF, Boscardin WJ, McArthur DL, Vespa P, Oertel M, Hovda DA, Bergsneider M, Hillered L, Martin NA. Energy dysfunction as a predictor of outcome after moderate or severe head injury: indices of oxygen, glucose, and lactate metabolism. J Cereb Blood Flow Metab. 2003 Oct;23(10):1239-50. doi: 10.1097/01.WCB.0000089833.23606.7F.

  PMID: 14526234 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Coma

Interventions

Sodium Lactate; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Paul Vespa, MD

CONTACT

800-825-2631; pvespa@mednet.ucla.edu

Manuel Buitrago-Blanco, MD

CONTACT

310-267-9448; mconsiglio@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant is not awake and is not told which arm they were randomized to Assessor is blinded to randomization allocation
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Assistant Dean

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start (Estimated): January 10, 2028
• Primary Completion (Estimated): December 30, 2035
• Study Completion (Estimated): July 1, 2038
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share