HypoperfusionNCT02846727
Using Fluorescence Angiography to Detect Occult Shock
An observational study of Hypoperfusion, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoperfusion
- What is being tested?
- skin perfusion image
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- Sepsis arm exclusion criteria:
- Pregnant
- Iodide allergy
- Burns
- Control arm exclusion criteria:
- Pregnant
Show all 9Show fewer
- Iodide allergy
- Burns
- Individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
The purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).
Read the 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
- Being tested
- skin perfusion image
- Keywords
- Hypoperfusion, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin perfusion imageDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Group | This group will consist of surgical intensive care patients with diagnosis of sepsis, severe sepsis, or septic shock. Receives: 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. Receives: Device: skin perfusion image |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoperfusionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Pei, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846727
- Sponsor's protocol ID
- 1509016441
- Status last verified
- Jan 2018
- First submitted
- 25 Jul 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Fluorescence Angiography to Detect Occult Shock
- ClinicalTrials.gov ID
- NCT02846727
- Acronym / sponsor ID
- 1509016441
- Conditions
- Hypoperfusion
- Keywords
- Hypoperfusion, Sepsis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis Group | – | Device: skin perfusion imageThis group will consist of surgical intensive care patients with diagnosis of sepsis, severe sepsis, or septic shock. |
| Control Group | – | Device: skin perfusion imageThis group will consist of patients that serve as controls who do not have diagnosis of sepsis, severe sepsis, or septic shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (23 listed)
- 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:
- Hepatic dysfunction as evidenced by:
- Control arm inclusion criteria:
Key exclusion criteria (9 listed)
- Sepsis arm exclusion criteria:
- Control arm exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin perfusion imageUpon 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. | Device | Control Group, Sepsis Group |
Primary outcome
Skin Perfusion Value
Time frame: Up to 6 hours
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoperfusion
RecruitingObservational study
Natural History Study of CADASIL
Cardiovascular Disease, Arterial Stiffness
RecruitingObservational study
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction
RecruitingObservational study
Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury
Brain Injuries, Traumatic, Brain Injuries, Acute
RecruitingPhase 2
Brain Blood Vessel Responses to Changes in Blood Flow
Magnetic Resonance Imaging, Cerebrovascular Circulation
RecruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Pei, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoperfusion, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Perfusion Value (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.