search
Back to results

Use of Salt-Water Solution to Improve Symptoms in Concussion

Primary Purpose

Brain Concussion, Post-Concussion Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3% Hypertonic saline
Placebo
Sponsored by
Rady Children's Hospital, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring Brain Concussion, Post-Concussion Syndrome, Closed Head Injury, Traumatic Brain Injury, Hypertonic Saline Solution

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Greater than or equal to 6 years of age Admitted for observation of closed head injury GCS greater than or equal to 13 Presence of headache CT scan showing no brain injury or only a small contusion (an area of low attenuation less than 10 mm or a punctuate area of high attenuation with surrounding edema less than 5mm). CT evidence of high or mixed attenuation would be consistent with a hemorrhagic lesion and therefore not qualify to participate in the study. Evidence of skull fractures and cephalohematomas on CT would not exclude the patient from the study. Exclusion Criteria: Age less than 6 GCS less than 13 Radiographic evidence of extra-axial blood or subarachnoid blood Possible or witnessed posttraumatic seizure Developmental delay/ mental retardation Underlying cardiac or renal pathology Suspected and/or documented use of alcohol and/or illicit substances Medication history which includes administration of acetaminophen within 4 hours prior to enrollment or chronic anticoagulant use (ie: Coumadin, Aspirin Associated injuries requiring the use of narcotics for analgesia (ie: long bone injuries, deep laceration repair) Intubation Non-English speaking No parental consent

Sites / Locations

  • Children's Hospital San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2

1

Arm Description

3% Hypertonic saline

Normal saline

Outcomes

Primary Outcome Measures

Improvement in headache.

Secondary Outcome Measures

Improvement in other clinical symptoms of concussion (decrease level of GCS, nausea, vomiting, inability to recall events, repetitive questioning, and disorientation to person, place, and time).

Full Information

First Posted
September 1, 2005
Last Updated
February 2, 2009
Sponsor
Rady Children's Hospital, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT00142090
Brief Title
Use of Salt-Water Solution to Improve Symptoms in Concussion
Official Title
Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rady Children's Hospital, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find out if 3% hypertonic saline (salt-water solution) given in a vein improves the headache that may be caused by a concussion. 3% hypertonic saline may also improve some of the other symptoms that may be caused by concussion (for example: confusion, nausea, vomiting). This research is being done because there have been previous experience which suggests that 3% hypertonic saline has been beneficial in the treatment of children with more severe brain injury.
Detailed Description
A concussion is formally described as a clinical syndrome characterized by immediate and transient changes in brain function including alteration of mental status and level of consciousness, resulting from mechanical force or trauma. Despite its prevalence, its pathophysiology remains a mystery as does its spectrum of clinical presentation. A concussion, sometimes described as a mild traumatic brain injury (TBI), can often present with initial loss of consciousness, change in behavior, confusion, amnesia, or aphasia which all result in a Glasgow Coma Scale (GCS) that is less than normal. As the time from the initial injury lengthens, these symptoms can progressively worsen and new symptoms such as vomiting and headaches can also develop. Usually, there is no evidence of a significant intracranial injury by computed tomography (CT) imaging and these symptoms often improve with a gradual progression towards a normal neurologic baseline; in fact, the risk of complication in this population is very rare. The time for this improvement varies greatly and can occur over a period ranging from hours to days. During this transient time, the patient is often very uncomfortable due to persistent headaches, inability to tolerate oral intake due to nausea and/or vomiting, confusion, and episodes of amnesia. In some instances, the combative behavior of the patient can be difficult to tolerate both by the family and the medical staff. Just as the symptoms caused by a concussion vary greatly in presentation and duration, so do the theories behind the pathophysiology of mild TBI. The transient loss of cerebral function after a head injury was formally differentiated from severe head injury for the first time by the Persian physician Rhazes in 900 AD and has since caused much speculation and varying clinical descriptions throughout history. It took another 500 years before a "commotion" or shaking of the brain was theorized to be responsible for clinical signs. Presently, the exact cause of concussive symptoms continue to remain an enigma; a major question however, is whether a concussion is due to a lesser degree of diffuse structural change seen in severe traumatic brain injury, or if it is in fact a mechanism caused by reversible functional changes of the neurons and axons. Animal models have demonstrated altered metabolic profiles of the brain tissue which resolves within hours of initial insult. Other animal models have demonstrated a change in the integrity of the microvascular endothelium after TBI. It can be hypothesized that there are areas of "microcontusion" and pericontusional edema that maybe responsible for alterations in brain chemistry which may ultimately lead to the clinical symptoms associated with mild TBI. Multiple other studies have theorized that the direct and indirect effects of trauma on cerebral vasculature may lead to a vasoconstrictive phenomenon that may be responsible for postconcussive symptoms. Currently, the management of patients with mild traumatic brain injuries includes observation and symptomatic therapies including analgesia without obscuring a neurologic exam (acetaminophen) and antiemetic measures (ondansetron). While many patients are often discharged home after initial evaluation in the Emergency Department, some are admitted to the hospital for supportive care. The symptoms may resolve in a period of hours to days. There has been substantial retrospective data and limited prospective data in children which suggests that hypertonic saline (HTS) can improve the control of intracranial pressure (ICP) in patients with acute brain injury. In 1992, a report published by the Journal of Neurosurgical Anesthesiology indicated that HTS reduced elevated ICP in children after head injury. This study looked at a single intravenous bolus of HTS in comparison to the same volume of normal saline and demonstrated a clear difference. Subsequently, it was demonstrated that HTS appears to be efficacious in controlling ICP. In a retrospective chart review, 68 children with closed head injury were cared for using a standardized protocol and the intravenous infusion of 3% HTS in quantities designed to drive the serum sodium to levels that would reduce the ICP to less than 20 mmHg. Of the patients in who HTS was used, only 3 patients (4%) died of uncontrolled ICP. Of note, there were no adverse effects of super-physiologic hyperosmolarity such as renal failure, pulmonary edema, or central pontine demyelination. The use of 3% hypertonic saline in traumatic brain injury has recently been investigated by many centers and is now included as first tier therapy in the management of decreasing intracranial pressure (ICP) secondary to severe traumatic brain injury in the pediatric population. Its mechanism in ICP reduction lies in its favorable rheologic and osmolar gradient effects; it concomitantly augments intravascular volume and increase mean arterial pressure to provide optimum cerebral perfusion pressure. Again, multiple studies have shown the direct effect of HTS in lowering ICP along with its safety in a pediatric population. HTS has also been used to treat altered mental status in diabetic ketoacidosis. Many of the symptoms associated with mild traumatic brain injury may be due to mild elevations in intracranial pressure, minimal cerebral edema, and/or vasospasm of the cerebral vasculature. Hypertonic saline may be instrumental in improving the symptoms of concussion by addressing the commonly suspected mechanisms responsible for these symptoms. By reducing mild cerebral edema and/or improving cerebral perfusion pressure, cerebral vasospasm may be overcome by reversal or by improved flow; thus, 3% HTS may allow favorable treatment of postconcussive symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Post-Concussion Symptoms
Keywords
Brain Concussion, Post-Concussion Syndrome, Closed Head Injury, Traumatic Brain Injury, Hypertonic Saline Solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
3% Hypertonic saline
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
3% Hypertonic saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Improvement in headache.
Secondary Outcome Measure Information:
Title
Improvement in other clinical symptoms of concussion (decrease level of GCS, nausea, vomiting, inability to recall events, repetitive questioning, and disorientation to person, place, and time).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Greater than or equal to 6 years of age Admitted for observation of closed head injury GCS greater than or equal to 13 Presence of headache CT scan showing no brain injury or only a small contusion (an area of low attenuation less than 10 mm or a punctuate area of high attenuation with surrounding edema less than 5mm). CT evidence of high or mixed attenuation would be consistent with a hemorrhagic lesion and therefore not qualify to participate in the study. Evidence of skull fractures and cephalohematomas on CT would not exclude the patient from the study. Exclusion Criteria: Age less than 6 GCS less than 13 Radiographic evidence of extra-axial blood or subarachnoid blood Possible or witnessed posttraumatic seizure Developmental delay/ mental retardation Underlying cardiac or renal pathology Suspected and/or documented use of alcohol and/or illicit substances Medication history which includes administration of acetaminophen within 4 hours prior to enrollment or chronic anticoagulant use (ie: Coumadin, Aspirin Associated injuries requiring the use of narcotics for analgesia (ie: long bone injuries, deep laceration repair) Intubation Non-English speaking No parental consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim T Rafaat, MD
Organizational Affiliation
Rady Children's Hospital, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley M Peterson, MD
Organizational Affiliation
Rady Children's Hospital, San Diego
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Use of Salt-Water Solution to Improve Symptoms in Concussion

We'll reach out to this number within 24 hrs