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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457817
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

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.


Condition or disease Intervention/treatment Phase
COVID Device: CRI management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: COVID-19 patients who require 2 liters of oxygen by nasal cannula (to maintain SpO2 >90%), will be eligible. Study participants will be randomized into standard of care and study patient cohorts. Both cohorts will receive standard monitoring and therapy. 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 acute kidney injury (AKI) and/or need for continuous renal replacement therapy (CRRT); and 4) improves clinical outcomes.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: 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 management
Patients in the CRI cohort will be monitored with the goal to maintain their supine CRI values 0.9 - 0.7 (mean 0.8).

No Intervention: Standard of Care
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). This cohort will receive the standard of care.



Primary Outcome Measures :
  1. Volume of IV fluid infused [ Time Frame: 1 year ]
    Volume of IV fluid infused during treatment

  2. Quantity of Blood pressure medication administered [ Time Frame: 1 year ]
    Amount of blood pressure medication utilized during treatment

  3. Resuscitation status [ Time Frame: 1 year ]
    Categorical determination of resuscitation status as over- or under- resuscitated

  4. FiO2 needs [ Time Frame: 1 year ]
    FiO2 levels administered

  5. Days on Oxygen [ Time Frame: 1 year ]
    Days spent on oxygen

  6. Number of participants with hospital acquired pneumonia [ Time Frame: 1 year ]
    Number of participants with hospital acquired pneumonia

  7. Number of Patients with Acute Kidney Injury (AKI) [ Time Frame: 1 year ]
    Number of patients who acquire an acute kidney injury

  8. 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

  9. mortality [ Time Frame: 1 year ]
    Number of patients who experience mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457817


Contacts
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Contact: Marina Reppucci, MD 203-731-4914 marina.reppucci@childrenscolorado.org
Contact: Jenny Stevens, MD 2515899950 jenny.stevens@childrenscolorado.org

Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
Investigators
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Principal Investigator: Steven L Moulton, MD Children's Hospital Colorado
Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04457817    
Other Study ID Numbers: 20-1406
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers

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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
Keywords provided by University of Colorado, Denver:
CRI
Compensatory Reserve Index
COVID-19
Coronavirus