Using Fluorescence Angiography to Detect Occult Shock

NCT02846727 | Withdrawn DMC

• 1 other identifier: 1509016441
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoperfusion

Keywords

Hypoperfusion; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sepsis Group

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

Device: skin perfusion image

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

Interventions

skin perfusion image 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; Sepsis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Pei, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 27, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

US (1)