Using Fluorescence Angiography to Detect Occult Shock
Withdrawn before enrolling
Conditions studied: Hypoperfusion
In brief
The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).
Key facts
- Study ID
- NCT02846727
- Run by
- Yale University
- People needed
- 0
- Starts
- 2016-08-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2018-01-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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