COVIDNCT04457817

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

An observational study of COVID, run by University of Colorado, Denver at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: COVID
What is being tested?: CRI
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 8 Apr 2021
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: COVID-19 positive patients, Eligibility described above.

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: 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.

Conditions: COVID
Being tested: CRI
Keywords: CRI, Compensatory Reserve Index, COVID-19, Coronavirus
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRIDevice
Monitoring via CRI

Study groups in NCT04457817
Study group	Role	What they receive
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. Receives: Device: CRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20208 Apr 2021

First posted7 Jul 2020
Study start1 Dec 2020
Primary completion8 Apr 2021
Study completion8 Apr 2021

Why it stopped: Lack of feasibility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for COVIDStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe 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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04457817
Sponsor's protocol ID: 20-1406
Status last verified: Nov 2021
First submitted: 24 Jun 2020
Last updated: 11 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to make individual participant data available to other researchers

Publications

Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.
PubMed 32224769
Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.
PubMed 21795890
Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.
PubMed 24256681
Convertino VA, Schiller AM. Measuring the compensatory reserve to identify shock. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S57-S65. doi: 10.1097/TA.0000000000001430. No abstract available.
PubMed 28333834
Janak JC, Howard JT, Goei KA, Weber R, Muniz GW, Hinojosa-Laborde C, Convertino VA. Predictors of the Onset of Hemodynamic Decompensation During Progressive Central Hypovolemia: Comparison of the Peripheral Perfusion Index, Pulse Pressure Variability, and Compensatory Reserve Index. Shock. 2015 Dec;44(6):548-53. doi: 10.1097/SHK.0000000000000480.
PubMed 26529655
Poh PY, Carter R 3rd, Hinojosa-Laborde C, Mulligan J, Grudic GZ, Convertino VA. Respiratory pump contributes to increased physiological reserve for compensation during simulated haemorrhage. Exp Physiol. 2014 Oct;99(10):1421-6. doi: 10.1113/expphysiol.2014.081208. Epub 2014 Jul 11.
PubMed 25016024
Van Sickle C, Schafer K, Mulligan J, Grudic GZ, Moulton SL, Convertino VA. A sensitive shock index for real-time patient assessment during simulated hemorrhage. Aviat Space Environ Med. 2013 Sep;84(9):907-12. doi: 10.3357/asem.3606.2013.
PubMed 24024301
Carter R 3rd, Hinojosa-Laborde C, Convertino VA. Variability in integration of mechanisms associated with high tolerance to progressive reductions in central blood volume: the compensatory reserve. Physiol Rep. 2016 Feb;4(4):e12705. doi: 10.14814/phy2.12705.
PubMed 26884477
Hinojosa-Laborde C, Howard JT, Mulligan J, Grudic GZ, Convertino VA. Comparison of compensatory reserve during lower-body negative pressure and hemorrhage in nonhuman primates. Am J Physiol Regul Integr Comp Physiol. 2016 Jun 1;310(11):R1154-9. doi: 10.1152/ajpregu.00304.2015. Epub 2016 Mar 30.
PubMed 27030667
Stewart CL, Mulligan J, Grudic GZ, Convertino VA, Moulton SL. Detection of low-volume blood loss: compensatory reserve versus traditional vital signs. J Trauma Acute Care Surg. 2014 Dec;77(6):892-7; discussion 897-8. doi: 10.1097/TA.0000000000000423.
PubMed 25423536
Nadler R, Convertino VA, Gendler S, Lending G, Lipsky AM, Cardin S, Lowenthal A, Glassberg E. The value of noninvasive measurement of the compensatory reserve index in monitoring and triage of patients experiencing minimal blood loss. Shock. 2014 Aug;42(2):93-8. doi: 10.1097/SHK.0000000000000178.
PubMed 24667628
Convertino VA, Howard JT, Hinojosa-Laborde C, Cardin S, Batchelder P, Mulligan J, Grudic GZ, Moulton SL, MacLeod DB. Individual-Specific, Beat-to-beat Trending of Significant Human Blood Loss: The Compensatory Reserve. Shock. 2015 Aug;44 Suppl 1:27-32. doi: 10.1097/SHK.0000000000000323.
PubMed 25565640
Stewart CL, Mulligan J, Grudic GZ, Talley ME, Jurkovich GJ, Moulton SL. The Compensatory Reserve Index Following Injury: Results of a Prospective Clinical Trial. Shock. 2016 Sep;46(3 Suppl 1):61-7. doi: 10.1097/SHK.0000000000000647.
PubMed 27172155
Johnson MC, Alarhayem A, Convertino V, Carter R 3rd, Chung K, Stewart R, Myers J, Dent D, Liao L, Cestero R, Nicholson S, Muir M, Schwacha M, Wampler D, DeRosa M, Eastridge B. Compensatory Reserve Index: Performance of A Novel Monitoring Technology to Identify the Bleeding Trauma Patient. Shock. 2018 Mar;49(3):295-300. doi: 10.1097/SHK.0000000000000959.
PubMed 28767544
Johnson MC, Alarhayem A, Convertino V, Carter R 3rd, Chung K, Stewart R, Myers J, Dent D, Liao L, Cestero R, Nicholson S, Muir M, Schwaca M, Wampler D, DeRosa M, Eastridge BJ. Comparison of compensatory reserve and arterial lactate as markers of shock and resuscitation. J Trauma Acute Care Surg. 2017 Oct;83(4):603-608. doi: 10.1097/TA.0000000000001595.
PubMed 28930955

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19
ClinicalTrials.gov ID: NCT04457817
Acronym / sponsor ID: 20-1406
Conditions: COVID
Keywords: CRI, Compensatory Reserve Index, COVID-19, Coronavirus
Study type: Observational
Recruitment status: TerminatedReason stopped: Lack of feasibility
Enrolment: 16 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Children's Hospital Colorado
Study start: 1 Dec 2020 (actual)
Primary completion: 8 Apr 2021 (actual)
Study completion: 8 Apr 2021 (actual)
First posted: 7 Jul 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.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
CRI Monitoring/Management	–	Device: CRIThese 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: COVID-19 positive patients, Eligibility described above.

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (7 listed)

COVID-19 negative
Age <18 or >70 years
On <2 liters oxygen via nasal canula
Pregnant
Incarcerated

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
CRIMonitoring via CRI	Device	CRI Monitoring/Management

Primary outcome

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

Results and safety

The study was stopped early (reason given: Lack of feasibility). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
Background: PubMed 32224769Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Crit Care Med. 2020 Jun;48(6):e440-e469. doi: 10.1097/CCM.0000000000004363.
Background: PubMed 21795890Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.
Background: PubMed 24256681Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.
Background: PubMed 28333834Convertino VA, Schiller AM. Measuring the compensatory reserve to identify shock. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S57-S65. doi: 10.1097/TA.0000000000001430. No abstract available.
Background: PubMed 26529655Janak JC, Howard JT, Goei KA, Weber R, Muniz GW, Hinojosa-Laborde C, Convertino VA. Predictors of the Onset of Hemodynamic Decompensation During Progressive Central Hypovolemia: Comparison of the Peripheral Perfusion Index, Pulse Pressure Variability, and Compensatory Reserve Index. Shock. 2015 Dec;44(6):548-53. doi: 10.1097/SHK.0000000000000480.
Background: PubMed 25016024Poh PY, Carter R 3rd, Hinojosa-Laborde C, Mulligan J, Grudic GZ, Convertino VA. Respiratory pump contributes to increased physiological reserve for compensation during simulated haemorrhage. Exp Physiol. 2014 Oct;99(10):1421-6. doi: 10.1113/expphysiol.2014.081208. Epub 2014 Jul 11.
Background: PubMed 24024301Van Sickle C, Schafer K, Mulligan J, Grudic GZ, Moulton SL, Convertino VA. A sensitive shock index for real-time patient assessment during simulated hemorrhage. Aviat Space Environ Med. 2013 Sep;84(9):907-12. doi: 10.3357/asem.3606.2013.
Background: PubMed 26884477Carter R 3rd, Hinojosa-Laborde C, Convertino VA. Variability in integration of mechanisms associated with high tolerance to progressive reductions in central blood volume: the compensatory reserve. Physiol Rep. 2016 Feb;4(4):e12705. doi: 10.14814/phy2.12705.
Background: PubMed 27030667Hinojosa-Laborde C, Howard JT, Mulligan J, Grudic GZ, Convertino VA. Comparison of compensatory reserve during lower-body negative pressure and hemorrhage in nonhuman primates. Am J Physiol Regul Integr Comp Physiol. 2016 Jun 1;310(11):R1154-9. doi: 10.1152/ajpregu.00304.2015. Epub 2016 Mar 30.
Background: PubMed 25423536Stewart CL, Mulligan J, Grudic GZ, Convertino VA, Moulton SL. Detection of low-volume blood loss: compensatory reserve versus traditional vital signs. J Trauma Acute Care Surg. 2014 Dec;77(6):892-7; discussion 897-8. doi: 10.1097/TA.0000000000000423.
Background: PubMed 24667628Nadler R, Convertino VA, Gendler S, Lending G, Lipsky AM, Cardin S, Lowenthal A, Glassberg E. The value of noninvasive measurement of the compensatory reserve index in monitoring and triage of patients experiencing minimal blood loss. Shock. 2014 Aug;42(2):93-8. doi: 10.1097/SHK.0000000000000178.
Background: PubMed 25565640Convertino VA, Howard JT, Hinojosa-Laborde C, Cardin S, Batchelder P, Mulligan J, Grudic GZ, Moulton SL, MacLeod DB. Individual-Specific, Beat-to-beat Trending of Significant Human Blood Loss: The Compensatory Reserve. Shock. 2015 Aug;44 Suppl 1:27-32. doi: 10.1097/SHK.0000000000000323.
Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers

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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.

Steven L Moulton, MD principal investigator

Children's Hospital Colorado

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 COVID, run by University of Colorado, Denver 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Nov 2021. 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 was stopped early (reason given: Lack of feasibility). Results are not available in the source record.

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?

Volume of IV fluid infused (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04457817, which also lists 31 linked publications.

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 11 Nov 2021.