Sodium Lactate in Severe TBI

Sponsor
University of California, Los Angeles
Study ID
NCT06701760
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sodium Lactate — DRUG
    sodium lactate
  • placebo — DRUG
    infusion of sodium chloride

Study Details

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.

Key Dates

First listed
Nov 22, 2024
Start date
Jan 10, 2028
Status verified
Jan 2026
Primary completion
Dec 30, 2035
Completion
Jul 1, 2038

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: intervention
    sodium lactate
  • Placebo Comparator: placebo
    sodium cbloride infusion

Primary Outcome Measure

mortality [ Time Frame: 30 days ]

Central Contacts

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