Please select the eligibility criteria that correspond to the clinical trial below.
Title: Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study
Brief Summary: The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.


Options:
A: Inclusion Criteria:

* Level 2 trauma patients admitted to the trauma floors or trauma ICU at Westchester Medical Center
* Experienced fear at the time of the trauma

Exclusion Criteria:

* Vulnerable populations, such as pregnant women, prisoners, persons with decisional incapacity.
* History of coronary artery disease, heart failure, prior stroke, heart surgery
* Bood pressure \>160/90
* Acutely psychotic
* Current diagnosis of anorexia nervosa, bulimia
* Current diagnosis of cancer
* Drug abuse or dependence in the preceding 3 months,
* Any unstable medical condition
* Active suicidal/homicidal ideation
* Cannot speak, read, write and understand English at least at 8th grade level.
B: Inclusion Criteria:

* Experienced an acute psychological traumatic event
* Heart rate of 80 beats per minute (bpm) or greater
* Understands English

Exclusion Criteria:

* Traumatic event that occurred more than four hours before arrival to emergency department
* Physical injury that may affect safe participation (e.g., head injury)
* Systolic blood pressure less than 100 mm Hg
* Medical or surgical condition that poses a risk of shock
* Medical condition that may affect the safe administration of propranolol
* Previous adverse reaction to, or non-compliance with, a beta-blocker
* Current use of medication that may react badly with propranolol
* Elevated saliva alcohol level
* Presence of salivary opiates, marijuana, cocaine, or amphetamines
* Pregnant or breastfeeding
* Traumatic event reflecting ongoing victimization
* Psychiatric condition that may affect safe participation
* Unwilling or unable to commute to Boston for research visits
* Attending physician in emergency department does not advise participation
C: Inclusion Criteria:

1. Clinical evidence of infection within the previous 72 hours (may be present longer than 72 hours) (a, b, c, or d - only 1 required)

   1. Presence of polymorphonuclear cells in a normally sterile body fluid (excluding blood);
   2. Culture or Gram stain of blood, sputum, urine or normally sterile body fluid positive for a pathogenic micro-organism;
   3. Focus of infection identified by visual inspection (e.g. ruptured bowel with the presence of free air or bowel contents in the abdomen found at the time of surgery, wound with purulent drainage);
   4. Other clinical evidence of infection - treated community acquired pneumonia, purpura fulminans, necrotising fascitis, etc.
2. Evidence of a systemic response to infection as defined by the presence of two or more of the following signs within the previous 24 hours. These signs may be present longer than 72 hours.

   1. Fever (temperature \>38.3°C) or hypothermia (rectal temperature \< 35.6°C);
   2. Tachycardia (heart rate of \>90 beat/min);
   3. Tachypnea (respiratory rate \> 20 breaths/min, PaC02\<32 mmHg) or patient requires invasive mechanical ventilation;
   4. Alteration of the WBC count \>12,000 cells/mm3, \<4,000 cells/mm3 or \>10% immature neutrophils (bands).
3. Evidence of shock defined by (A + B- both required within the previous 72 hours (may NOT be present longer than 72 hours).

A. A systolic blood pressure \< 90 mmHg or a decrease in SBP of more than 50 mmHg from baseline in previous hypertensive patients (for at least one hour) despite adequate fluid replacement OR need for vasopressors for at least one hour (infusion of dopamine ≥ 5 mcg/kg/min or any dose of adrenaline, noradrenaline, phenylephrine or vasopressin) to maintain a SBP ≥ 90 mmHg;

B. Hypoperfusion or organ dysfunction which is not the result of underlying diseases or drugs, but is attributable to sepsis, including one of the following:

1. Sustained oliguria (urine output \< 0.5 ml/kg/hr for a minimum of 1 hour)
2. Metabolic acidosis \[pH of \< 7.3, or a base deficit of \> or = 5.0 mmol/L, or an increased lactic acid concentration (\> 2 mmol/L)\].
3. Arterial hypoxemia (Pa02/FI02\<280 in the absence of pneumonia)(Pa02/FI02\<200 in the presence of pneumonia).
4. Thrombocytopenia - platelet count ≤ 100,000 cells/mm3.
5. Acute altered mental status (Glasgow Coma Scale \< 14 or acute change from baseline).

4. Informed Consent

5. Cortisol level at baseline and 60 minutes after 0.25 mg cosyntropin

Exclusion Criteria:

1. Pregnancy
2. Age less than 18.
3. Underlying disease with a prognosis for survival of less than 3 months.
4. Cardiopulmonary resuscitation within 72 hours before study.
5. Drug-induced immunosuppression, including chemotherapy or radiation therapy within 4 weeks before the study.
6. Administration of chronic corticosteroids in the last 6 months or acute steroid therapy (any dose) within 4 weeks (including inhaled steroids). Topical steroids are not exclusions.
7. HIV positivity.
8. Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
9. Advanced cancer with a life expectancy less than 3 months.
10. Acute myocardial infarction or pulmonary embolus.
11. Another experimental drug study within the last 30 days.
12. Moribund patients likely to die within 24 hours.
13. Patients in the ICU for more than 2 months at the time of the start of septic shock.
D: 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.

Answer: C