Hypoperfusion Clinical Trial
Official title:
Using Fluorescence Angiography to Detect Occult Shock
Verified date | January 2018 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin Perfusion Value | We aim to obtain a SPI within 6 hours of enrollment. Skin perfusion images produced by LUNA have computerized, graded quantification of fluorescein intensity (values 0-256). The mean score will be used to compare Sepsis and Control arms. | Up to 6 hours |
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