Please select the eligibility criteria that correspond to the clinical trial below.
Title: Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study
Brief Summary: This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in mechanically ventilated trauma patients.

The study population will be adults admitted to the ICU due to multiple-trauma or head trauma as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.


Options:
A: Inclusion Criteria:

1. Males and females aged 18-90 years with multiple-trauma or head trauma admitted to the ICU.
2. Enteral nutrition can be initiated within 36 hours of admission/ injury.
3. Mechanical ventilation.

Exclusion criteria:

1. Severe underlying systemic disease and /or treatment with immunosuppressive agents.
2. Contra-indication for Enteral Nutrition (mechanical or functional bowel. obstruction, high-output fistula, severe necrotizing pancreatitis).
3. 2nd /3rd degree burns covering \> 66% BSA.
4. Pregnancy.
5. Participants under the age of 18.
B: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Patients must provide acceptable proof of identity documentation to confirm initials and date of birth
3. Male and female patients aged 21 to 65 years, inclusive.
4. All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 12 weeks after their last dose. All females must have a negative serum pregnancy test. Women of childbearing potential (WOCBP, see below) must use a highly effective form of birth control plus the use of a condom by the male sexual partner, reviewed and approved by the PI. The highly effective form of birth control includes: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD/IUS, Depo-Provera injections, oral contraceptive, and Evra Patch or Nuvaring. Women should be on a stable method of birth control for a minimum of 3 months , prior to randomization and 3 months after the last dose of IP.

   Women of non-childbearing potential. Women of non-childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they are amenorrheic for 12 months prior to randomization without an alternative medical cause. The following age-specific requirements apply:

   Women \< 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.

   Women ≥ 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
5. CAPS-5 score ≥ 25 and CGI-S ≥ 4 at Screening and Randomization
6. Anxiety Potentiated Startle T-score ≥ 2.8.
7. Psychotropic medications must remain at a stable dose for at least 42 days prior to screening, without clinically significant adjustment.
8. Be able to understand and comply with the requirements of the study, as judged by the investigator

Exclusion Criteria:

1. Patients who are currently participating in another clinical study in which the patient is exposed to an investigational or non-investigational drug or device, or have done so within the last 30 days prior to screening.
2. Patients who have no regular contact with an adult who could come to the patient's aid should an urgent need arise.
3. Patients with a history of DSM-5 diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, or currently exhibiting psychotic symptoms associated with depression; dementia or suspicion thereof, is also exclusionary.
4. Currently being treated with MAOIs, lithium, divalproex, carbamazepine, barbiturates, or benzodiazepines. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[eg, riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine\], or the mu-opioid receptor.
5. Patients who meet DSM-5 criteria for substance use disorder (amphetamines, cocaine, hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics) within 1 month prior to screening. Patients with a positive urine drug screen (UDS) are excluded except for patients testing positive for prescribed medications that are otherwise permitted and there is no evidence of misuse or abuse. Patients can be re-tested only if either the initial opiate or barbiturate result is positive and they have a prescription, but the patient should be excluded if the result is still positive at the second test. Patients with positive UDS for drug(s) legally available by prescription must provide evidence of prescription for the drug(s).
6. Patients with a binge-pattern of alcohol use which makes them at risk for withdrawal-related seizures. Also, significant alcohol withdrawal symptoms that require medical detoxification.
7. Patients with a suicide attempt within the last 3 months or at imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigator.
8. Patients who are pregnant or lactating.
9. Clinically significant laboratory value, physical examination, or ECG that signifies a major medical illness that is unstable or inadequately controlled, or that may put the subject at risk during the study in the judgment of the investigator. Hypothyroidism is permitted if corrected and the patient is on a stable treatment regimen for a minimum of 6 months.
10. Systolic BP \< 85 or \> 160 mmHg or diastolic BP \> 100 mmHg or heart rate \< 50 or \>105 beats per minute at Screening or Randomization. Exclusionary values may be repeated once.
11. QTcF (Fridericia-corrected) ≥ 450 msec at Screening or Randomization. Exclusionary values may be repeated once.
12. Patients with any history of seizure disorder (except for febrile seizures in childhood) or traumatic brain injury.
13. Previous exposure to lanicemine.
14. Patients with a personality disorder which in the opinion of the investigator has a major impact on the patient's current psychiatric status and would preclude safe study participation.
15. Body mass index (BMI) ≥ 40 kg/m2
C: Inclusion Criteria:

1. Age ≥ 18 years
2. Weight: 99 lb - 242 lbs
3. Experienced a traumatic event less than 6 hours ago

Secondary Inclusion Criteria:

ED staff note marked anxiety emotional distress and or dissociation in relation to index trauma as assessed by meeting a minimum of 2 out of 4 of the peritraumatic characteristics that have been associated with the development of PTSD below:

1. Anxiety Visual Analog Scale minimum score of 4 on a scale of 0 to 10
2. Peritraumatic dissociation (PDEQ) with a cut-point of 15 (lowest possible score is 10)
3. Peritraumatic distress (Peritraumatic Distress Inventory) (PDI) with a cut-point of 15 (lowest possible score is 0)
4. Heart rate at 80 bpm or more

Exclusion Criteria:

1. Severe physical injury as assessed with the Abbreviated Injury Scale (AIS \> 2); Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by clinical judgment.
2. Inability to provide informed consent or cooperate with the screening or collection of initial measures.
3. Intoxication to a degree that would interfere with the ability to provide informed consent or high level or intoxication reported at the time of trauma.
4. Moderate to severe head injury associated with current trauma exposure as defined by a loss of consciousness \>30 minutes following injury.
5. Medical conditions e.g., Cushing's syndrome, current acute infectious or viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, heart failure.
6. Currently taking oral steroids
7. Use of benzodiazepine within 24 hours of trauma exposure will not be eligible to participate in the study
8. Individuals prescribed a narcotic medication to alleviate acute pain in the ED will not be eligible to participate in the treatment study.
9. Weight below 45kg or above 110 kg (99 lbs - 242 lbs)
10. Pregnancy (a urine pregnancy test will be performed in the ED)
11. Individuals experiencing on-going trauma (i.e., domestic violence).
12. Reported diagnoses of schizophrenia, bipolar I disorder, or other psychotic illness.
13. Current or past history of dementia, amnesia or other cognitive disorder predating trauma exposure
14. Residence outside local area, which would hinder attendance at follow up visits due to long travel time.
D: Inclusion Criteria:

* Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn
* Between the ages of 6 - 20 years
* Recent experience of an acute burn, injury, or surgery meeting the Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion
* Child's response to the stressor meets Diagnostic and Statistical Manual(DSM-IV) A2 response criterion
* Proficiency in either English or Spanish

Exclusion Criteria:

* No memory of the injury
* Current use of an anti-depressant
* Known hypersensitivity to sertraline
* Diagnosis of Bipolar Disorder
* Diagnosis of PTSD
* Mental Retardation
* Traumatic Brain Injury
* New onset or marked worsening of a seizure disorder

Answer: A