SepsisNCT04529655
Digital Capillary Refill for Monitoring of Sepsis
An observational study of Sepsis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Observational study for monitoring of capillary refill time in sepsis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Capillary Refill Assessment
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Observational study for monitoring of capillary refill time in sepsis
Read the detailed description
This is an observational studying assessing changes in capillary refill time over the course of sepsis treatment.
- Conditions
- Sepsis
- Being tested
- Capillary Refill Assessment
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary Refill AssessmentDevice
Device to quantify capillary refill time
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Patients admitted to the ICU with sepsis will be enrolled and monitored at time sequential time points during their treatment Receives: Device: Capillary Refill Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lactate Level
Correlation of Capillary refill to blood lactate
Measured: during procedure
Secondary outcomes (2)
Vasoactive
Correlation of capillary refill to need for vasoactive medications
Measured: 24 hours
28 day hospital mortality
Correlation of initial capillary refill time to 28 day hospital mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start12 Aug 2020
- Primary completion30 Jun 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Sheridan, Oregon Health and Science University
- Investigators
- David Sheridan, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529655
- Sponsor's protocol ID
- STUDY00021286
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2020
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Capillary Refill for Monitoring of Sepsis
- ClinicalTrials.gov ID
- NCT04529655
- Acronym / sponsor ID
- STUDY00021286
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Device: Capillary Refill AssessmentPatients admitted to the ICU with sepsis will be enrolled and monitored at time sequential time points during their treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary Refill AssessmentDevice to quantify capillary refill time | Device | Sepsis |
Primary outcome
Blood lactate Level
Time frame: during procedure
Correlation of Capillary refill to blood lactate
2 secondary outcomes
Vasoactive
Time frame: 24 hours
28 day hospital mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sheridan, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lactate Level (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.