Using Fluorescence Angiography to Detect Occult Shock

NCT ID: NCT02846727

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-09-30

Brief Summary

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

Detailed 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.

Conditions

Hypoperfusion

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Sepsis Group

This group will consist of surgical intensive care patients with diagnosis of sepsis, severe sepsis, or septic shock.

skin perfusion image

Intervention Type: DEVICE

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.

Control Group

This group will consist of patients that serve as controls who do not have diagnosis of sepsis, severe sepsis, or septic shock.

skin perfusion image

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Do not have diagnosis of sepsis, severe sepsis, or septic shock
• Are not on vasopressors
• Are normo-thermic

Exclusion Criteria

• Pregnant
• Iodide allergy
• Burns

• Pregnant
• Iodide allergy
• Burns
• Individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Pei, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1509016441

Identifier Type: -

Identifier Source: org_study_id