Digital Capillary Refill for Monitoring of Sepsis

Recruiting

• Conditions: Sepsis
• Interventions: Device: Capillary Refill Assessment

• Registration Number: NCT04529655
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2020-08-12
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-06-30
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis	Capillary Refill Assessment	Patients admitted to the ICU with sepsis will be enrolled and monitored at time sequential time points during their treatment

Primary Outcome Measures

Name	Time	Method
Blood lactate Level	during procedure	Correlation of Capillary refill to blood lactate

Secondary Outcome Measures

Name	Time	Method
28 day hospital mortality	28 days	Correlation of initial capillary refill time to 28 day hospital mortality
Vasoactive	24 hours	Correlation of capillary refill to need for vasoactive medications

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States