Hemodynamic Characteristics of Patients With SARS-CoV-2 (PiCCOVID)

• ClinicalTrials.gov Identifier: NCT04337983
• Recruitment Status: Completed
• First Posted: April 8, 2020
• Last Update Posted: September 14, 2021
• Sponsor: Bicetre Hospital
• Information provided by (Responsible Party): Xavier Monnet, Bicetre Hospital

Tracking Information

• First Submitted Date: March 30, 2020
• First Posted Date: April 8, 2020
• Last Update Posted Date: September 14, 2021
• Actual Study Start Date: March 13, 2020
• Actual Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2020)

• Body temperature [ Time Frame: Through study completion, an estimation of 6 months ]
  Body temperature(°C)
• Blood pressure [ Time Frame: Through study completion, an estimation of 6 months ]
  Blood pressure in mmHg
• Pulse (heart rate) [ Time Frame: Through study completion, an estimation of 6 months ]
  Pulse (heart rate) in times/minute
• Respiratory rate [ Time Frame: Through study completion, an estimation of 6 months ]
  Respiratory rate in times/minute
• Data provided by transpulmonary thermodilution-CI [ Time Frame: Through study completion, an estimation of 6 months ]
  Cardiac index (L/min/m2)
• Data provided by transpulmonary thermodilution-GEDV [ Time Frame: Through study completion, an estimation of 6 months ]
  Global end-diastolic volume(mL/m2)
• Data provided by transpulmonary thermodilution-EVLW [ Time Frame: Through study completion, an estimation of 6 months ]
  Extravascular lung water (mL/kg)
• Data provided by transpulmonary thermodilution-PVPI [ Time Frame: Through study completion, an estimation of 6 months ]
  Pulmonary vascular permeability index
• Incidence of abnormal laboratory test results [ Time Frame: Through study completion, an estimation of 6 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 3, 2020)

• Incidence of new-onset or reversible systolic left ventricular dysfunction [ Time Frame: Through study completion, an estimation of 6 months ]
  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
• Changes of extravascular lung water measured by transpulmonary thermodilution [ Time Frame: Change from baseline extravascular lung water at 6 months ]
  The worst extravascular lung water
• Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution [ Time Frame: Change from baseline extravascular lung water at 6 months ]
  The worst pulmonary vascular permeability index
• Correlation between the hemodynamic characteristics and 90-day mortality [ Time Frame: Up to 90th day after inclusion ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hemodynamic Characteristics of Patients With SARS-CoV-2
• Official Title: Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study
• Brief 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.
• Detailed 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: SARS-Cov2 positive patients admitted to ICU and monitored by transpulmonary thermodilution system will be included.

Condition

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

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)
• Device: Echocardiography
  Daily echocardiography evaluation

• Study Groups/Cohorts: Not Provided

Publications *

• 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. Erratum In: Nature. 2020 Dec;588(7836):E6.
• 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.
• 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.
• 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.
• 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;:
• 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.
• 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. No abstract available. Erratum In: Intensive Care Med. 2020 Apr 6;:
• 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.
• 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. No abstract available.
• Schuster DP. The search for "objective" criteria of ARDS. Intensive Care Med. 2007 Mar;33(3):400-2. doi: 10.1007/s00134-006-0499-5. Epub 2007 Jan 13. No abstract available.
• 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.
• Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
• Shi R, Lai C, Teboul JL, Dres M, Moretto F, De Vita N, Pham T, Bonny V, Mayaux J, Vaschetto R, Beurton A, Monnet X. COVID-19 ARDS is characterized by higher extravascular lung water than non-COVID-19 ARDS: the PiCCOVID study. Crit Care. 2021 Jun 1;25(1):186. doi: 10.1186/s13054-021-03594-6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 24, 2021): 60
• Original Estimated Enrollment (submitted: April 3, 2020): 200
• Actual Study Completion Date: November 30, 2020
• Actual Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04337983
• Other Study ID Numbers: 2020-A00793-36
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Xavier Monnet, Bicetre Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Bicetre Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bicetre Hospital
• Verification Date: September 2021