Early Induced Hypernatremia for the Prevention and Management of Brain Edema

NCT02798601 | Withdrawn DMC

• 2 other identifiers: U1111-1183-0891HPTU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head Trauma

Keywords

Cerebral edema; Hypernatremia; Extended Glasgow Outcome Scale; Intracranial pressure; Mannitol; Hypertonic saline; Mortality

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale Extended

  The Extended Glasgow Outcome Scale (GOSE) is a global scale for functional outcome that rates patients into eight categories. The categories of severe disability, moderate disability and good recovery are subdivided into a lower and upper category. The scale will be used to evaluate the patient through a phone interview at 6 months of the trauma occurred. The structured interview contains nineteen specific questions which determine upper or lower levels of disability.

  6 months

Secondary Outcomes (8)

• All-cause mortality

  28 - day AND 180 - day mortality

• Ventilator - Free Days

  30 days

• Fluid balance.

  5 days

• Acute kidney injury

  7 days

• Intracranial pressure (ICP) measurement

  5 days

Study Arms (2)

Hypernatremia

EXPERIMENTAL

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.

Other: Hypernatremia

Normonatremia

NO INTERVENTION

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.

Interventions

Hypernatremia OTHER

Serum Sodium goal: 150 - 155 milliequivalent/L.

Hypernatremia

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Pablo Tobón Uribe: lead
• CES University: collaborator

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Edema; Hypernatremia

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Juan C Lopez de Mesa, MD

  Hospital Pablo Tobon Uribe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2016
• First Posted: June 14, 2016
• Study Start: January 18, 2017
• Primary Completion: January 18, 2017
• Study Completion: January 18, 2018
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share