Digital Capillary Refill for Monitoring of Sepsis

Observational study for monitoring of capillary refill time in sepsis

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Device: Capillary Refill Assessment

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: David Sheridan, MD; Phone Number: 503-494-1691; Email: sheridda@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU
      • Contact: David Sheridan, MD MCR; Phone Number: 503-494-1691; Email: sheridda@ohsu.edu
      • Contact: Matt Hansen, MD MCR; Email: hansemat@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lactate Level	Correlation of Capillary refill to blood lactate	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasoactive	Correlation of capillary refill to need for vasoactive medications	24 hours
28 day hospital mortality	Correlation of initial capillary refill time to 28 day hospital mortality	28 days

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: David Sheridan, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2020
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: STUDY00021286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No