Early Induced Hypernatremia for the Prevention and Management of Brain Edema

NCT ID: NCT02798601

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2018-01-18

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.

Conditions

Head Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hypernatremia

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.

Group Type: EXPERIMENTAL

Hypernatremia

Intervention Type: OTHER

Serum Sodium goal: 150 - 155 milliequivalent/L.

Normonatremia

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypernatremia

Serum Sodium goal: 150 - 155 milliequivalent/L.

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CES University

OTHER

Sponsor Role: collaborator

Hospital Pablo Tobón Uribe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan C Lopez de Mesa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Pablo Tobon Uribe

Other Identifiers

HPTU

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1183-0891

Identifier Type: -

Identifier Source: org_study_id