Please select the eligibility criteria that correspond to the clinical trial below.
Title: KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
Brief Summary: In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.


Options:
A: Inclusion Criteria:

Patients admitted in intensive care units for septic shock and meeting all following criteria

* Proven infection
* Need for vasopressor to maintain systemic arterial tension above 90 mmHg
* Multiple organ dysfunction as defined by a SOFA score ³ 8.
* Need for treatment with moderate dose of corticosteroids

Exclusion Criteria:

One of the following :

* Pregnancy
* Less than 18 years old
* Moribund (i.e. expected to die on day of intensive care unit admission)
B: Inclusion Criteria:

1. Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP.
2. CAP will be defined by a new infiltrate on chest radiograph and the presence of one or several of the following acute respiratory signs or symptoms:

   * cough
   * sputum production
   * dyspnea
   * core body temperature \>38.0° C
   * auscultatory findings of abnormal breath sounds and rales
   * leukocyte count \>10 or \<4 x 109 cells L-1 (1)

Exclusion Criteria:

1. Patients or family members unable to give written informed consent, e.g. with severe dementia.
2. Patients with active intravenous drug use.
3. Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count \< 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values \< 500 x 109/L); patients with cystic fibrosis as well as patients with active tuberculosis.
4. Patients with acute burn injury
5. Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization
6. Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent
7. Pregnancy or breast feeding
8. Patients with known adrenal insufficiency
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:

* Adults admitted to ICU and anticipated to require intensive care for at least a few days

Exclusion Criteria:

* Expected short ICU stay
* Therapy restricted upon admission
* Surgical ICU patients
* Other studies
* Below 18 years
* Pregnancy

Answer: D