Head TraumaEHIBENCT02798601
Early Induced Hypernatremia for the Prevention and Management of Brain Edema
A study testing Hypernatremia in people with Head Trauma, run by Hospital Pablo Tobón Uribe.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Head Trauma
- What is being tested?
- Hypernatremia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2017to 18 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Pregnancy.
- Terminal disease.
- No authorization to be enrolled in the trial by the patient's caregiver
About this study
Official title: Early Induced Hypernatremia for the Prevention and Management of Brain Edema in Patients With Severe Traumatic Brain Injury in a University Hospital
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.
Read the 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
- Being tested
- Hypernatremia
- Keywords
- Cerebral edema, Hypernatremia, Extended Glasgow Outcome Scale, Intracranial pressure, Mannitol, Hypertonic saline, Mortality
- Medical subject headings
- Craniocerebral Trauma, Brain Edema, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypernatremiaOther
Serum Sodium goal: 150 - 155 milliequivalent/L.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
All-cause mortality
Mortality by any cause
Measured: 28 - day AND 180 - day mortality
Ventilator - Free Days
Days free of mechanical ventilation at 30 days
Measured: 30 days
Fluid balance.
Net fluid balance (input minus output) (ml) at day 1,2,3,4 y 5.
Measured: 5 days
Acute kidney injury
Acute kidney injury (KDIGO criteria). The criteria for acute kidney injury(AKI) are based on changes in serum creatinine (SCr) and urine output.
Stage I : Increase in SCr more than 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days OR increase in SCr more than 0.3 mg/dL within 48 hours OR urine output <0.5 ml/kg/h for 6-12h.
Stage II : Increase in SCr between 2.0 - 2.9 times baseline, which is known or presumed to have occurred within the prior 7 days OR urine output <0.5 ml/kg/h for more than 12 hours.
Stage III : Increase more than 3.0 times baseline, which is known or presumed to have occurred within the prior 7 days OR Increase in serum creatinine to 4.0 mg/dL OR Initiation of renal-replacement therapy OR urine output <0.3 ml/kg/h for more than 24 hours OR Anuria for more than 12 hours.
Measured: 7 days
Intracranial pressure (ICP) measurement
Intracranial pressure measurement (mmHg) during the first 5 days at the ICU. Estimate the effect of therapies to control intracranial pressure. An intraparenchymal catheter will used to measure the ICP. Intracranial pressure (ICP) will be measured every hour. Intracranial hypertension will be defined as ICP > 20 mm Hg lasting longer than 5 minutes.
Measured: 5 days
Need of second line therapies for brain edema
Secondary decompressive craniectomy or barbituric coma for control of brain edema.
Measured: 7 days
All-cause mortality according to subgroups of monitoring: guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring.
Estimate the effects of therapies on mortality according to subgroups of treatment (guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring).
Measured: 28 - day AND 180 - day mortality
Glasgow Outcome Scale Extended (GOSE) according to subgroups of monitoring: guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring.
Estimate the effects of therapies on the GOSE according to subgroups of treatment (guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start18 Jan 2017 (estimated)
- Primary completion18 Jan 2017 (estimated)
- Study completion18 Jan 2018 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pablo Tobón Uribe
- Sponsor type
- University, hospital or other
- Collaborators
- CES University
- Responsible party
- Sponsor
- Investigators
- Juan C Lopez de Mesa, MD, Principal investigator, Hospital Pablo Tobon Uribe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798601
- Sponsor's protocol ID
- U1111-1183-0891
- Other IDs
- HPTU
- Acronym
- EHIBE
- Status last verified
- Sep 2023
- First submitted
- 21 May 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Induced Hypernatremia for the Prevention and Management of Brain Edema in Patients With Severe Traumatic Brain Injury in a University Hospital
- ClinicalTrials.gov ID
- NCT02798601
- Acronym / sponsor ID
- EHIBE / U1111-1183-0891
- Conditions
- Head Trauma
- Keywords
- Cerebral edema, Hypernatremia, Extended Glasgow Outcome Scale, Intracranial pressure, Mannitol, Hypertonic saline, Mortality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Pablo Tobón UribeUniversity, hospital or other
- Collaborators
- CES University
- Study start
- 18 Jan 2017 (estimated)
- Primary completion
- 18 Jan 2017 (estimated)
- Study completion
- 18 Jan 2018 (estimated)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypernatremia | Experimental | Other: HypernatremiaSerum 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. |
| 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypernatremiaSerum Sodium goal: 150 - 155 milliequivalent/L. | Other | Hypernatremia |
Primary outcome
Glasgow Outcome Scale Extended
Time frame: 6 months
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.
8 secondary outcomes
All-cause mortality
Time frame: 28 - day AND 180 - day mortality
Ventilator - Free Days
Time frame: 30 days
Fluid balance.
Time frame: 5 days
Acute kidney injury
Time frame: 7 days
Intracranial pressure (ICP) measurement
Time frame: 5 days
Need of second line therapies for brain edema
Time frame: 7 days
All-cause mortality according to subgroups of monitoring: guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring.
Time frame: 28 - day AND 180 - day mortality
Glasgow Outcome Scale Extended (GOSE) according to subgroups of monitoring: guided by neurologic examination and serial CT imaging or guided by intracranial pressure monitoring.
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Head Trauma
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Lopez de Mesa, MD principal investigator
Hospital Pablo Tobon Uribe
Questions about this trial
What is this clinical trial studying?
A study testing Hypernatremia in people with Head Trauma, run by Hospital Pablo Tobón Uribe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extended (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.