Digital Capillary Refill for Monitoring of Sepsis

NCT04529655 | Completed

• 1 other identifier: STUDY00021286
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Observational study for monitoring of capillary refill time in sepsis

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Blood lactate Level

  Correlation of Capillary refill to blood lactate

  during procedure

Secondary Outcomes (2)

• Vasoactive

  24 hours

• 28 day hospital mortality

  28 days

Study Arms (1)

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

Interventions

Capillary Refill Assessment DEVICE

Device to quantify capillary refill time

Sepsis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Sheridan, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: August 12, 2020
• Primary Completion: June 30, 2023
• Study Completion: November 1, 2023
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)