WithdrawnNot Applicable

Early Induced Hypernatremia for the Prevention and Management of Brain Edema

Stopped: Lack of funds

0Started 2017-01-18

Plain-language summary

The purpose of this study is to estimate the effect of an early induced hypernatremia protocol (150-155 milliequivalent/L) versus normonatremia plus mannitol (135 - 145 milliequivalent/L) in terms of neurologic outcome in patients with severe traumatic brain injury managed at critical care unit.

Who can participate

Age range14 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

✓. 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.

What they're measuring

Glasgow Outcome Scale Extended

Timeframe: 6 months

Trial details

NCT IDNCT02798601

SponsorHospital Pablo Tobón Uribe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-18

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