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Brain ConcussionNCT00142090

Use of Salt-Water Solution to Improve Symptoms in Concussion

A study testing 3% Hypertonic saline in people with Brain Concussion and Post-Concussion Symptoms, run by Rady Children's Hospital, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Brain Concussion, Post-Concussion Symptoms
What is being tested?
3% Hypertonic saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteUnited States
Study dates
Nov 2004to Jul 2007
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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital San Diego

    San Diego, California, 92123

Other trials in United States

About this study

Official title: Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients

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.

Read the 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.

Being tested
3% Hypertonic saline, Placebo
Keywords
Brain Concussion, Post-Concussion Syndrome, Closed Head Injury, Traumatic Brain Injury, Hypertonic Saline Solution
Medical subject headings
Brain Concussion, Post-Concussion Syndrome, Head Injuries, Closed, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3% Hypertonic salineDrug

  • PlaceboDrug

    Normal saline

Study groups in NCT00142090
Study groupRoleWhat they receive
2Experimental3% Hypertonic saline
Receives: Drug: 3% Hypertonic saline
1Placebo comparatorNormal saline
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in headache.

Secondary outcomes (1)
  1. 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionDec 2005
  4. Study completionJul 2007

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00142090
Sponsor's protocol ID
04139-C
Other IDs
11266
Status last verified
Jan 2009
First submitted
1 Sep 2005
Last updated
3 Feb 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing 3% Hypertonic saline in people with Brain Concussion and Post-Concussion Symptoms, run by Rady Children's Hospital, San Diego at 1 site in United States.

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 5 inclusion and 12 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: finished, as of the sponsor's last update on 3 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Improvement in headache.. 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 3 Feb 2009.

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