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Not Yet RecruitingPhase 1ACTRN12625000178448

An open label pilot study of 30% sodium asCOrbate aS OSMOtherapy in patientS with traumatic brain injury and raised intracranial pressure- The COSMOS study

An open label pilot feasibility study of 30% sodium asCOrbate aS OSMOtherapy in patientS with traumatic brain injury and raised intracranial pressure

Sponsor

Central Adelaide Local Health Network

Enrollment

12 participants

Start Date

Dec 3, 2025

Study Type

Interventional

Conditions

traumatic intracranial hypertension

Summary

The goal of COSMOS is to conduct an open label feasibility study of hypertonic sodium ascorbate for the management of intracranial hypertension in traumatic brain injury

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Adult patients (age 18 years or above) with moderate to severe TBI
  • Insertion of invasive neuromonitoring as per the treating clinical team
  • Potential to require osmotherapy for the management of intracranial hypertension.

Exclusion Criteria14

  • Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
  • Advanced care directive or previously stated wish not to be included in research activities
  • Bilateral fixed and dilated pupils and/or deemed to be non-survivable by treating clinical team
  • Pre-existing end stage renal failure, Child B or C liver disease,
  • Known G6PD deficiency or G6PD positivity on BinaxNOWTM G6PD Point-of-Care Qualitative Rapid Diagnostic Test (Lake Forest, Illinois, USA)
  • Plasma sodium > 150 mmol/L
  • Plasma sodium < 130 mmol/L
  • eGFR < 30 mL/min/1.73m2
  • Type 1 diabetes mellitus
  • History of ketoacidosis
  • Use of SGLT2 Inhibitors
  • Sickle cell disease
  • Confirmed or suspected pregnancy
  • History of oxalate renal stones

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Interventions

Enrolled participants will become eligible for delivery of the intervention if the intracranial pressure (ICP) is equal or more 20 mmHg for 5 minutes despite adequate sedation, positioning, and physio

Enrolled participants will become eligible for delivery of the intervention if the intracranial pressure (ICP) is equal or more 20 mmHg for 5 minutes despite adequate sedation, positioning, and physiological optimisation and/or the treating clinicians believe that it is necessary to provide immediate treatment for raised ICP. Dosing regimen A 60 ml of neat 30% sodium ascorbate (18 grams) will be infused through a dedicated lumen of a central venous catheter over 10 minutes. If the ICP remains equal or above 20 mmHg for more 5 minutes 60 minutes post the first dose, a second bolus dose of 40 mL of neat 30% sodium ascorbate (12 grams) will be infused through a dedicated lumen of a central venous catheter over 10 minutes. Patients will only receive sodium ascorbate once during their ICU admission if their ICP increases above 20 mmHg. The duration of administration is maximum of 20 minutes. Any staff providing the intervention (Either ICU nurse or the treating physician) will receive protocol training. Intervention administration will be recorded in the medical records and used to monitor protocol adherence.

Locations(1)

SA, Australia

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ACTRN12625000178448