Clinical trial NCT04529655: Digital Capillary Refill for Monitoring of Sepsis
Official title: Digital Capillary Refill for Monitoring of Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: Observational study for monitoring of capillary refill time in sepsis

Detailed description: This is an observational studying assessing changes in capillary refill time over the course of sepsis treatment.

Eligibility 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

Primary outcomes:
measure: Blood lactate Level
timeFrame: during procedure
Secondary outcomes:
measure: Vasoactive
timeFrame: 24 hours
measure: 28 day hospital mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Sheridan, MD
role: PRINCIPAL_INVESTIGATOR
References: