Sodium Lactate in Severe TBI (NCT06701760) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sodium Lactate in Severe TBI
264 participantsStarted 2028-01-10
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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