Hemodynamic Characteristics of Patients With SARS-CoV-2

COVID-19 Clinical Trial

— PiCCOVID  

Official title:

Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337983
• Other study ID #: 2020-A00793-36
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2021
• Source: Bicetre Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been declared a public health emergency of international concern. Hospitalized COVID-19-positive patients requiring ICU care is increasing along with the course of epidemic. A large number of these patients developed acute respiratory distress syndrome (ARDS) according to current data. However, the related hemodynamic characteristic has so far been rarely described.

Description:

The outbreak of COVID-19 is a worldwide concern. To our knowledge, the details of the hemodynamic characteristics of COVID-19 patients have not yet been well described. Besides, the cardiac injury was reported in about 7-17% of hospitalized patients with COVID-19 in previous Chinese publications and is much more common in patients admitted to ICU and non-survivors. However, no systematic assessment, including echocardiography evaluating the left ventricular function of these patients has been declared. In addition, extravascular lung water (EVLW) and pulmonary capillary permeability are two hall markers in ARDS patient's management, and transpulmonary thermodilution is a validated method to provide these values at the bedside. However, no study has reported the characteristic profile of these variables during ARDS caused by SARS-Cov2. A better knowledge of these characteristics would also be helpful in guiding their management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Confirmed or suspected SARS-Cov2 cases
• Patients admitted to ICU, defined as a unit in which patients can receive vasopressors.
• Monitored by a transpulmonary thermodilution system (PiCCO2 (Pulsion Medical Systems, Feldkirchen, Germany) or EV1000 (Edwards Lifesciences, Irvine, United States of America).

Exclusion Criteria:

• SARS Cov-2 Negative
• Refusal to participate in the study

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Coronavirus
• COVID-19
• Fluid Overload
• Left Ventricular Dysfunction
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• SARS-CoV-2
• Shock
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Transpulmonary thermodilution
Obtained by averaging the results of three thermodilution measurements. Each thermodilution is performed by injecting a bolus (15 mL) of cold saline (less than 10°C)
• Echocardiography
Daily echocardiography evaluation

Locations

Country	Name	City	State
France	Bicetre Hospital	Paris	Val-de-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

References & Publications (12)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. — View Citation

Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19. Review. — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Jozwiak M, Silva S, Persichini R, Anguel N, Osman D, Richard C, Teboul JL, Monnet X. Extravascular lung water is an independent prognostic factor in patients with acute respiratory distress syndrome. Crit Care Med. 2013 Feb;41(2):472-80. doi: 10.1097/CCM.0b013e31826ab377. — View Citation

Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5. Review. — View Citation

Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. Erratum in: Intensive Care Med. 2020 Apr 6;:. — View Citation

Schuster DP. The search for "objective" criteria of ARDS. Intensive Care Med. 2007 Mar;33(3):400-2. Epub 2007 Jan 13. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113. — View Citation

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. — View Citation

Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body temperature	Body temperature(°C)	Through study completion, an estimation of 6 months
Primary	Blood pressure	Blood pressure in mmHg	Through study completion, an estimation of 6 months
Primary	Pulse (heart rate)	Pulse (heart rate) in times/minute	Through study completion, an estimation of 6 months
Primary	Respiratory rate	Respiratory rate in times/minute	Through study completion, an estimation of 6 months
Primary	Data provided by transpulmonary thermodilution-CI	Cardiac index (L/min/m2)	Through study completion, an estimation of 6 months
Primary	Data provided by transpulmonary thermodilution-GEDV	Global end-diastolic volume(mL/m2)	Through study completion, an estimation of 6 months
Primary	Data provided by transpulmonary thermodilution-EVLW	Extravascular lung water (mL/kg)	Through study completion, an estimation of 6 months
Primary	Data provided by transpulmonary thermodilution-PVPI	Pulmonary vascular permeability index	Through study completion, an estimation of 6 months
Primary	Incidence of abnormal laboratory test results		Through study completion, an estimation of 6 months
Secondary	Incidence of new-onset or reversible systolic left ventricular dysfunction	Left ventricle ejection fraction, Segmental left ventricle contractility, Speckle tracking data of the left and right ventricles, Dimensions of right and left cavities and Diastolic function of left ventricle	Through study completion, an estimation of 6 months
Secondary	Changes of extravascular lung water measured by transpulmonary thermodilution	The worst extravascular lung water	Change from baseline extravascular lung water at 6 months
Secondary	Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution	The worst pulmonary vascular permeability index	Change from baseline extravascular lung water at 6 months
Secondary	Correlation between the hemodynamic characteristics and 90-day mortality		Up to 90th day after inclusion