Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT02846727
Eligibility Criteria:
Inclusion Criteria:
* Sepsis arm inclusion criteria:
* Diagnosis of severe sepsis and septic shock.
* Sepsis is defined as at least two of the following signs and symptoms (SIRS) that are both present and new to the patient and suspicion of new infection:
* Hyperthermia \>38.3°C or Hypothermia \<36°C
* Tachycardia \>90 bpm
* Tachypnea \>20 bpm
* Leukocytosis (\>12,000 μL-1) or Leukopenia (\<4,000 μL-1) or \>10% bands.
* Hyperglycemia (\>120 mg/dl) in the absence of diabetes.
* Severe sepsis includes SIRS and at least one of the following signs of hypoperfusion or organ dysfunction that is new and not explained by other known etiology of organ dysfunction:
* Hypotension (\<90/60 or MAP \<65)
* Lactate \>2
* Areas of mottled skin or capillary refill \>3 seconds
* Creatinine \>2.0 mg/dl
* Disseminated intravascular coagulation (DIC), Platelet count \<100,000
* Acute renal failure or urine output \<0.5 ml/kg/hr for at least 2 hours
* Hepatic dysfunction as evidenced by:
* Bilirubin \>2 or INR \>1.5
* Cardiac dysfunction
* Acute lung injury or ARDS
* Control arm inclusion criteria:
* Do not have diagnosis of sepsis, severe sepsis, or septic shock
* Are not on vasopressors
* Are normo-thermic
Exclusion Criteria:
* Sepsis arm exclusion criteria:
* Pregnant
* Iodide allergy
* Burns
* Control arm exclusion criteria:
* Pregnant
* Iodide allergy
* Burns
* Individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02846727
Study Brief:
Protocol Section:
NCT02846727