Clinical trial NCT02798601: Early Induced Hypernatremia for the Prevention and Management of Brain Edema
Official title: Early Induced Hypernatremia for the Prevention and Management of Brain Edema in Patients With Severe Traumatic Brain Injury in a University Hospital
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head Trauma
Keywords: Cerebral edema
Hypernatremia
Extended Glasgow Outcome Scale
Intracranial pressure
Mannitol
Hypertonic saline
Mortality
Lead sponsor: Hospital Pablo Tobón Uribe
Sponsor class: OTHER
Collaborators: name: CES University
First posted: 2016-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Severe traumatic brain injury is one of the main causes of death in young people. Additionally, it is considered a public health problem because of the high prevalence of motor and cognitive dysfunction in those who survive.

One of the cornerstones of management is the control of both intracranial pressure and brain edema. It is indicated to use osmotic active solutions to modulate the transit of fluids from the interstitial to the intracellular space. Not only mannitol but also hypertonic saline acts at this point. Currently there is no evidence in favor or against one of them.

Mannitol has been usually recommended for intracranial pressure control in patients with brain trauma. However, others recommend hypertonic saline to achieve a serum sodium level of 160 milliequivalent/L to modulate brain edema. It is not clear if these therapies have an impact on the neurologic prognosis and how frequently adverse effects occur.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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:

1. 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).
2. Patient with insipid diabetes at the ICU admission.
3. Patient with limitation of therapeutic effort.
4. Non-neurological Abbreviated Injury Score greater than 3.
5. Patient past medical history of kidney failure, liver disease or heart failure.
6. Serum sodium less than 135 or greater than 150 milliequivalent/L.
7. Pregnancy.
8. Terminal disease.
9. No authorization to be enrolled in the trial by the patient's caregiver

Primary outcomes:
measure: Glasgow Outcome Scale Extended
timeFrame: 6 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 28 - day AND 180 - day mortality
measure: Ventilator - Free Days
timeFrame: 30 days
measure: Fluid balance.
timeFrame: 5 days
measure: Acute kidney injury
timeFrame: 7 days
measure: Intracranial pressure (ICP) measurement
timeFrame: 5 days
measure: Need of second line therapies for brain edema
timeFrame: 7 days
measure: All-cause mortality according to subgroups of monitoring: guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring.
timeFrame: 28 - day AND 180 - day mortality
measure: Glasgow Outcome Scale Extended (GOSE) according to subgroups of monitoring: guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring.
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Pablo Tobon Uribe
name: Juan C Lopez de Mesa, MD
role: PRINCIPAL_INVESTIGATOR
References: