Digital Capillary Refill for Monitoring of Sepsis

Sepsis Clinical Trial

Official title:

Digital Capillary Refill for Monitoring of Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529655
• Other study ID #: STUDY00021286
• Status: Recruiting
• Start date: August 12, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2022
• Source: Oregon Health and Science University
• Contact: David Sheridan, MD
• Phone: 503-494-1691
• Email: sheridda[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study for monitoring of capillary refill time in sepsis

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Device:
• Capillary Refill Assessment
Device to quantify capillary refill time

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lactate Level	Correlation of Capillary refill to blood lactate	during procedure
Secondary	Vasoactive	Correlation of capillary refill to need for vasoactive medications	24 hours
Secondary	28 day hospital mortality	Correlation of initial capillary refill time to 28 day hospital mortality	28 days