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Digital Capillary Refill for Monitoring of Sepsis

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ClinicalTrials.gov Identifier: NCT04529655
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. David Sheridan, Oregon Health and Science University

Study Description
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Brief Summary:
Observational study for monitoring of capillary refill time in sepsis

Condition or disease Intervention/treatment
Sepsis Device: Capillary Refill Assessment

Detailed Description:
This is an observational studying assessing changes in capillary refill time over the course of sepsis treatment.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digital Capillary Refill for Monitoring of Sepsis
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Sepsis
Patients admitted to the ICU with sepsis will be enrolled and monitored at time sequential time points during their treatment
 Device: Capillary Refill Assessment
Device to quantify capillary refill time


Outcome Measures
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Primary Outcome Measures :
  1. Blood lactate Level [ Time Frame: during procedure ]
    Correlation of Capillary refill to blood lactate


Secondary Outcome Measures :
  1. Vasoactive [ Time Frame: 24 hours ]
    Correlation of capillary refill to need for vasoactive medications

  2. 28 day hospital mortality [ Time Frame: 28 days ]
    Correlation of initial capillary refill time to 28 day hospital mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults admitted to the ICU, ED or inpatient floor with sepsis defined as a concern for an infection with either hemodynamic or respiratory organ failure on intravenous antibiotics will be eligible.
Criteria

Inclusion Criteria:

  1. Clinical evidence of a known or suspected infection and orders written for administration of IV antibiotics
  2. Hypotension as defined by the need for any vasopressor (and 1 liter of fluid already administered) OR respiratory failure defined by assisted ventilation (includes mechanical ventilation and BIPAP), CPAP, or greater than or equal to 6 liters/minute of supplemental oxygen

Exclusion Criteria:

  1. No consent/inability to obtain consent from the participant or a legally authorized representative
  2. Diagnosis of cirrhosis by medical chart review
  3. Liver transplant recipient
  4. AST or ALT greater than five times upper limit of normal
  5. Diagnosis of ongoing chronic alcohol use disorder/abuse by chart review; if medical record unclear, use Appendix F
  6. Clinical diagnosis of diabetic ketoacidosis or other condition such as profound hypoglycemia that requires hourly blood glucose monitoring
  7. Hypersensitivity to Acetaminophen or Vitamin C
  8. Patient, surrogate or physician not committed to full support (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
  9. Home assisted ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing
  10. Current active kidney stone
  11. Known history of oxalate kidney stones or history of oxalate nephropathy
  12. Kidney transplant recipient
  13. Use of home oxygen for chronic cardiopulmonary disease
  14. Moribund patient not expected to survive 24 hours
  15. Underlying malignancy or other condition with estimated life expectancy of less than 1 month
  16. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
  17. Prisoner
  18. Enrollment in another critical care based pharmacologic interventional trial
  19. Treating team unwilling to enroll because of intended use of Acetaminophen or Vitamin C
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529655


Contacts
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Contact: David Sheridan, MD 503-494-1691 sheridda@ohsu.edu

Locations
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United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: David Sheridan, MD MCR    503-494-1691    sheridda@ohsu.edu   
Contact: Matt Hansen, MD MCR       hansemat@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: David Sheridan, MD Oregon Health and Science University
More Information
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Responsible Party: Dr. David Sheridan, Assistant Professor of Emergency Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04529655    
Other Study ID Numbers: STUDY00021286
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes