Using Fluorescence Angiography to Detect Occult Shock

Hypoperfusion Clinical Trial

Official title:

Using Fluorescence Angiography to Detect Occult Shock

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02846727
• Other study ID #: 1509016441
• Status: Withdrawn
• Phase: N/A
• First received: July 25, 2016
• Last updated: January 9, 2018
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).

Description:

Hypoperfusion may be multifactorial, due to hemorrhage, shock or other disease processes resulting in either capillary leak into the interstitium or profound vasodilatation. Currently, diagnosis of hypoperfusion depends on indirect markers of perfusion such as lactate, blood pressure, creatinine, urine output, and mental status. These are all late signs of hypoperfusion as they are precursors to impending system failure. In this study, the focus will be on one of the most common causes of hypoperfusion in the surgical population; sepsis and septic shock.

Recruitment information / eligibility

• Status: Withdrawn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.

Related Conditions & MeSH terms

• Hypoperfusion

Intervention

Device:
• skin perfusion image
Upon enrollment following written, informed consent, the patient will receive an injection of 7.5 mg of Indocyanine Green (ICG) intravenously (Dilute 25 mg of Indocyanine Green (ICG) with 10 cc of solvent to achieve a 2.5 mg/cc concentration.) Following injection, Novadaq's LUNA™ fluorescence angiography system will be utilized to map a standard skin perfusion image (SPI) over the upper extremities and anterior chest wall.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

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