Early Induced Hypernatremia for the Prevention and Management of Brain Edema (EHIBE)
Head Trauma
About this trial
This is an interventional treatment trial for Head Trauma focused on measuring Cerebral edema, Hypernatremia, Extended Glasgow Outcome Scale, Intracranial pressure, Mannitol, Hypertonic saline, Mortality
Eligibility Criteria
Inclusion Criteria:
- Patient greater than 14 years old, who suffered severe non-penetrating Brain Trauma (Glasgow Coma Scale (GCS) equal or less than 8) and a motor GCS equal or less than 5.
- Criteria time: admitted to the Hospital in the first 24 hours of the Brain Trauma (BT) and admitted to ICU in the first 48 hours of brain trauma.
- Tomographic evidence of brain edema (one of the following criteria: deviation from the midline, obliteration of perimesencephalic cistern or altered cortico-subcortical differentiation).
Exclusion Criteria:
- Patient with GCS 3 and bilateral mydriatic pupils and unreactive to light, in the presence of hemodynamic stability (systolic blood pressure equal or greater than 90 mmHg).
- Patient with insipid diabetes at the ICU admission.
- Patient with limitation of therapeutic effort.
- Non-neurological Abbreviated Injury Score greater than 3.
- Patient past medical history of kidney failure, liver disease or heart failure.
- Serum sodium less than 135 or greater than 150 milliequivalent/L.
- Pregnancy.
- Terminal disease.
- No authorization to be enrolled in the trial by the patient's caregiver
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Hypernatremia
Normonatremia
Serum sodium between 150 - 155 milliequivalent/L. 7,5% sodium chloride (2 ml/kg every 4 hours), with controls of serum sodium every 4 hours, to achieve a goal of serum sodium between 150 - 155 milliequivalent/L. If after 4 doses of 7.5% sodium chloride the serum sodium is below the target, a bolus of 1 ml/kg of 12% sodium chloride will be used every 4 hours. The goal of serum sodium will be maintained for 48 hours.
Serum sodium between 135 - 145 milliequivalent/L. Mannitol 100 ml every 4 hours for the first three days; 80 ml every 4 hours the fourth day; 60 ml every 4 hours the fifth day and 40 ml every 4 hours the sixth day and then stopping. The mannitol protocol will be interrupted at any moment if serum sodium is below 135, the systolic blood pressure is below 90 mmHg or the patient has signs of hypovolemia. In this case, 2 ml/kg of 3% sodium chloride every 4 hours will be used until the target of serum sodium is achieved and both, normovolemic state and blood pressure are restored. In addition, the mannitol protocol will be suspended when serum osmolality is above 320.