Using Fluorescence Angiography to Detect Occult Shock

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

Study Overview

• Status: Withdrawn
• Conditions: Hypoperfusion
• Intervention / Treatment: Device: skin perfusion image

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients who are 1) primarily assigned to the Division of General Surgery, Trauma, and Surgical Critical Care and 2) admitted to the surgical intensive care units will be screened for eligibility based on enrollment criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis Group; This group will consist of surgical intensive care patients with diagnosis of sepsis, severe sepsis, or septic shock.	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.
Control Group; This group will consist of patients that serve as controls who do not have diagnosis of sepsis, severe sepsis, or septic shock.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Kevin Pei, MD, Yale University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Sepsis; Hypoperfusion
• Other Study ID Numbers: 1509016441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided