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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04457817
• Other study ID #: 20-1406
• Status: Terminated
• Start date: December 1, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: November 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

Device:
• CRI
Monitoring via CRI

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

References & Publications (31)

Alexander PMA, DiOrio M, Andren K, Gauvreau K, Mistry KP, Mathieu D, Wright J, Allan CK, Nathan M, Mayer JE Jr, Thiagarajan RR, Bergersen L. Accurate Prediction of Congenital Heart Surgical Length of Stay Incorporating a Procedure-Based Categorical Variable. Pediatr Crit Care Med. 2018 Oct;19(10):949-956. doi: 10.1097/PCC.0000000000001668. — View Citation

Alhazzani W, Møller 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. — View Citation

ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. — View Citation

Benov A, Brand A, Rozenblat T, Antebi B, Ben-Ari A, Amir-Keret R, Nadler R, Chen J, Chung KK, Convertino VA, Paran H. Evaluation of sepsis using compensatory reserve measurement: A prospective clinical trial. J Trauma Acute Care Surg. 2020 Aug;89(2S Suppl 2):S153-S160. doi: 10.1097/TA.0000000000002648. — View Citation

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). pii: e12705. doi: 10.14814/phy2.12705. — View Citation

Choi YM, Leopold D, Campbell K, Mulligan J, Grudic GZ, Moulton SL. Noninvasive monitoring of physiologic compromise in acute appendicitis: New insight into an old disease. J Pediatr Surg. 2018 Feb;53(2):241-246. doi: 10.1016/j.jpedsurg.2017.11.013. Epub 2017 Nov 13. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Convertino VA, Wampler MR, Johnson M, Alarhayem A, Le TD, Nicholson S, Myers JG, Chung KK, Struck KR, Cuenca C, Eastridge BJ. Validating clinical threshold values for a dashboard view of the compensatory reserve measurement for hemorrhage detection. J Trauma Acute Care Surg. 2020 Aug;89(2S Suppl 2):S169-S174. doi: 10.1097/TA.0000000000002586. — View Citation

Ehrmann DE, Leopold DK, Phillips R, Shahi N, Campbell K, Ross M, Zablah JE, Moulton SL, Morgan G, Kim JS. The Compensatory Reserve Index Responds to Acute Hemodynamic Changes in Patients with Congenital Heart Disease: A Proof of Concept Study. Pediatr Cardiol. 2020 Aug;41(6):1190-1198. doi: 10.1007/s00246-020-02374-3. Epub 2020 May 30. — View Citation

Erickson SE, Martin GS, Davis JL, Matthay MA, Eisner MD; NIH NHLBI ARDS Network. Recent trends in acute lung injury mortality: 1996-2005. Crit Care Med. 2009 May;37(5):1574-9. doi: 10.1097/CCM.0b013e31819fefdf. — View Citation

Ferreira FL, Bota DP, Bross A, Mélot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. — View Citation

Gagnon D, Schlader ZJ, Adams A, Rivas E, Mulligan J, Grudic GZ, Convertino VA, Howard JT, Crandall CG. The Effect of Passive Heat Stress and Exercise-Induced Dehydration on the Compensatory Reserve During Simulated Hemorrhage. Shock. 2016 Sep;46(3 Suppl 1):74-82. doi: 10.1097/SHK.0000000000000653. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratalà J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. Erratum in: Clin Infect Dis. 2017 May 1;64(9):1298. Erratum in: Clin Infect Dis. 2017 Oct 15;65(8):1435. Clin Infect Dis. 2017 Nov 29;65(12):2161. — View Citation

Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. — View Citation

Leopold DK, Phillips RC, Shahi N, Gien J, Marwan AI, Kinsella JP, Mulligan J, Liechty KW, Moulton SL. Low postnatal CRI values are associated with the need for ECMO in newborns with CDH. J Pediatr Surg. 2020 Jan;55(1):39-44. doi: 10.1016/j.jpedsurg.2019.09.050. Epub 2019 Oct 25. — View Citation

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. — View Citation

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. — View Citation

National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. Epub 2006 May 21. — View Citation

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. — View Citation

Silversides JA, Major E, Ferguson AJ, Mann EE, McAuley DF, Marshall JC, Blackwood B, Fan E. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. doi: 10.1007/s00134-016-4573-3. Epub 2016 Oct 12. Review. — View Citation

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. — View Citation

Stewart CL, Mulligan J, Grudic GZ, Pyle L, Moulton SL. A noninvasive computational method for fluid resuscitation monitoring in pediatric burns: a preliminary report. J Burn Care Res. 2015 Jan-Feb;36(1):145-50. doi: 10.1097/BCR.0000000000000178. — View Citation

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. — View Citation

Stewart CL, Nawn CD, Mulligan J, Grudic G, Moulton SL, Convertino VA. Compensatory Reserve for Early and Accurate Prediction of Hemodynamic Compromise: Case Studies for Clinical Utility in Acute Care and Physical Performance. J Spec Oper Med. 2016 Spring;16(1):6-13. — View Citation

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. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

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