Clinical trial NCT04457817: Compensatory Reserve Index (CRI) for Management of COVID-19
Official title: CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID
Keywords: CRI
Compensatory Reserve Index
COVID-19
Coronavirus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2020-07-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 positive patients, Eligibility described above.

Brief summary: The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label.

The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.


Eligibility criteria: Inclusion Criteria:

Eligible patients will be those who are:

* COVID-19 positive;
* Ages \> 18 and \< 70 years old;
* Require \> 2 liters of oxygen by nasal cannula to maintain SpO2 \> 90%;
* Are admitted to the sixth floor at University Hospital, on one of two designated Hospitalist services (approximately 16 COVID-19 positive patients/service).

Exclusion Criteria:

* COVID-19 negative
* Age \<18 or \>70 years
* On \<2 liters oxygen via nasal canula
* Pregnant
* Incarcerated
* DNR/DNI
* Decisionally Challenged

Primary outcomes:
measure: Volume of IV fluid infused
timeFrame: 1 year
measure: Quantity of Blood pressure medication administered
timeFrame: 1 year
measure: Resuscitation status
timeFrame: 1 year
measure: FiO2 needs
timeFrame: 1 year
measure: Days on Oxygen
timeFrame: 1 year
measure: Number of participants with hospital acquired pneumonia
timeFrame: 1 year
measure: Number of Patients with Acute Kidney Injury (AKI)
timeFrame: 1 year
measure: Number of patients with hemodynamic collapse
timeFrame: 1 year
measure: mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Steven L Moulton, MD
role: PRINCIPAL_INVESTIGATOR
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