Sodium Lactate in Severe TBI

January 14, 2026 updated by: Paul Vespa, MD, University of California, Los Angeles

Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Traumatic brain injury (TBI) consists of a primary localized insult to the brain followed by prolonged global disruption of brain metabolism, thus creating risk for secondary brain damage from energy deficiency. To date, there is no specific metabolic treatment to improve outcome after TBI. This study is designed to determine if providing a unique chemical fuel in the form sodium lactate will improve the brain's metabolism and prevent ongoing damage. The investigators will seek to find the highest dose of sodium lactate that is tolerated and then to determine if administering this dose for 24 hours improves brain metabolism and survival. We will collect blood and brain MRI images to test if the intervention helps brain metabolism and brain structure. The study will be a randomized trial so that we have a comparison group against which to best evaluate safety. Ten medical centers that are very experienced with traumatic brain injury will participate in the study and will be supervised by a data safety monitoring board. This is a pilot study that will ultimately inform the design of a large scale clinical trial of sodium lactate in the near future.

RATIONALE TBI has no definitive drug treatment, and multiple trials have failed. We propose a pilot safety study of a metabolic treatment for TBI using exogenous sodium lactate (ELI) infusion to enhance brain oxidative metabolism as a medical treatment for TBI.

STUDY DESIGN This is a multicenter phase 2 study. The phase 2a study will identify the maximum tolerated dose of ELI using the continual reassessment dose escalation design with three dose tiers and will be followed by a phase 2b, randomized, placebo-controlled comparison of the ELI at maximum tolerated dose (MTD) for 24 hours vs normal saline infusion. The time to enrollment and start of study infusion will be 24 hours after onset of TBI.

PRIMARY OBJECTIVE The primary objective of part 1, the dose finding study is to determine the maximum tolerated dose (MTD) associated with a prespecified probability of dose limiting toxicity (DLT). The DLT is defined as the occurrence within 7 days of ELI of any one of three adverse events: AKI, arrythmia (atrial or ventricular tachycardia that causes hypotension), or ARDS (mild or greater).

The primary objective of the part 2 of the study, the randomized trial of MTD ELI for 24 hours vs saline is 30 day mortality.

NUMBER OF SUBJECTS 264

SUBJECT SELECTION

CRITERIA Inclusion Criteria:

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

Exclusion Criteria:

  1. Penetrating TBI,
  2. Polytrauma leading to instability of systemic hemodynamics, acidosis, or severe acute lung injury during the inclusion period.
  3. History of neurological disease, including Parkinson's, Huntington's, Alzheimer's, etc.; History of diabetes mellitus;
  4. Serum sodium ≥ 148 mM; Metabolic acidosis pH <7.34;
  5. Coagulopathy INR > 1.3, platelets < 100,000, or hematocrit < 28 mg/dl;
  6. Renal insufficiency with GFR < 60% of expected or Cr > 1.3;

6. AST or ALT > 1.5x upper limit of normal; Severe liver trauma; 7. baseline serum lactate > 2 mM; 8. Hypotension SBP < 90 refractory to vasopressors; 9. Known mitochondrial genetic disorder; 10. Pregnancy; 11.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; 12.Member of a protected population; simultaneous participation in another randomized trial

Time Window Enrollment and study infusion starts within 24 hours of TBI

TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION Sodium Lactate Injection, USP diluted to 200 mg/mL Sodium Lactate.

Lactate will be administered continuously for up to 6 hours by IV (in part 1) and for 24 hours (in part 2) and titrated to achieve targeted blood lactate concentrations for the assigned dose tier. New IND is pending. Investigational Product to be made by Altasciences.

CONTROL PRODUCT, DOSE AND ROUTE OF ADMINISTRATION 0.9% Normal Saline will serve as placebo in part 2 of the study Saline infusion will be administered continuously for up to 24 hours in 24 hours in part 2 of the study

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Penetrating TBI
  • Polytrauma leading to instability of systemic: hemodynamics, acidosis, or severe acute lung injury during the inclusion period
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention
sodium lactate
Drug: Sodium Lactate
sodium lactate
Placebo Comparator: placebo
sodium cbloride infusion
Drug: placebo
infusion of sodium chloride
Other Names:
  • sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days
Mortality
30 days
Dose limiting toxicity
Time Frame: 7 days
panel of serious adverse events
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2028

Primary Completion (Estimated)

December 30, 2035

Study Completion (Estimated)

July 1, 2038

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-011590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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