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OpenTrials
Completed

NCT Number: NCT04529655

Digital Capillary Refill for Monitoring of Sepsis

Observational study for monitoring of capillary refill time in sepsis

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU

Portland, Oregon, 97239, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical evidence of a known or suspected infection and orders written for administration of IV antibiotics
  • 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

  • No consent/inability to obtain consent from the participant or a legally authorized representative
  • Diagnosis of cirrhosis by medical chart review
  • Liver transplant recipient
  • AST or ALT greater than five times upper limit of normal
  • Diagnosis of ongoing chronic alcohol use disorder/abuse by chart review; if medical record unclear, use Appendix F
  • Clinical diagnosis of diabetic ketoacidosis or other condition such as profound hypoglycemia that requires hourly blood glucose monitoring
  • Hypersensitivity to Acetaminophen or Vitamin C
  • 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)
  • Home assisted ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing
  • Current active kidney stone
  • Known history of oxalate kidney stones or history of oxalate nephropathy
  • Kidney transplant recipient
  • Use of home oxygen for chronic cardiopulmonary disease
  • Moribund patient not expected to survive 24 hours
  • Underlying malignancy or other condition with estimated life expectancy of less than 1 month
  • 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
  • Prisoner
  • Enrollment in another critical care based pharmacologic interventional trial
  • Treating team unwilling to enroll because of intended use of Acetaminophen or Vitamin C

Treatment and study plan

Capillary Refill Assessment

Device

Device to quantify capillary refill time

Primary outcomes

  1. Blood lactate Level

    Time frame: during procedure

    Correlation of Capillary refill to blood lactate

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2020
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.