Compensatory Reserve Index (CRI) for Management of COVID-19

November 3, 2021 updated by: University of Colorado, Denver

CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 positive patients, Eligibility described above.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRI Monitoring/Management
These patients 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). Patients in the study cohort will also be monitored with a CipherOx CR T1 tablet in a continuous manner to determine if maintaining CRI vales between 0.9-0.7 will: 1) help guide IV fluid (e.g. crystalloid, colloids, blood products) and medication therapy (e.g. diuretics); 2) allows earlier identification of patients who are poorly compensating and will require ICU level care; 3) reduces AKI and/or need for CRRT; and 4) improves clinical outcomes.
Device: CRI
Monitoring via CRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of IV fluid infused
Time Frame: 1 year
Volume of IV fluid infused during treatment
1 year
Quantity of Blood pressure medication administered
Time Frame: 1 year
Amount of blood pressure medication utilized during treatment
1 year
Resuscitation status
Time Frame: 1 year
Categorical determination of resuscitation status as over- or under- resuscitated
1 year
FiO2 needs
Time Frame: 1 year
FiO2 levels administered
1 year
Days on Oxygen
Time Frame: 1 year
Days spent on oxygen
1 year
Number of participants with hospital acquired pneumonia
Time Frame: 1 year
Number of participants with hospital acquired pneumonia
1 year
Number of Patients with Acute Kidney Injury (AKI)
Time Frame: 1 year
Number of patients who acquire an acute kidney injury
1 year
Number of patients with hemodynamic collapse
Time Frame: 1 year
Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg
1 year
mortality
Time Frame: 1 year
Number of patients who experience mortality
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

April 8, 2021

Study Completion (Actual)

April 8, 2021

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make individual participant data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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