Hemodynamic Characteristics of Patients With SARS-CoV-2

NCT04337983 | Completed

• 1 other identifier: 2020-A00793-36
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hemodynamic chracteristics; Transpulmonary thermodilution; Preload-dependency; Echocardiography; Extravascular lung water; Pulmonary vascular permeability index

Outcome Measures

Primary Outcomes (9)

• Body temperature

  Body temperature(°C)

  Through study completion, an estimation of 6 months

• Blood pressure

  Blood pressure in mmHg

  Through study completion, an estimation of 6 months

• Pulse (heart rate)

  Pulse (heart rate) in times/minute

  Through study completion, an estimation of 6 months

• Respiratory rate

  Respiratory rate in times/minute

  Through study completion, an estimation of 6 months

• Data provided by transpulmonary thermodilution-CI

  Cardiac index (L/min/m2)

  Through study completion, an estimation of 6 months

• Data provided by transpulmonary thermodilution-GEDV

  Global end-diastolic volume(mL/m2)

  Through study completion, an estimation of 6 months

• Data provided by transpulmonary thermodilution-EVLW

  Extravascular lung water (mL/kg)

  Through study completion, an estimation of 6 months

• Data provided by transpulmonary thermodilution-PVPI

  Pulmonary vascular permeability index

  Through study completion, an estimation of 6 months

• Incidence of abnormal laboratory test results

  Through study completion, an estimation of 6 months

Secondary Outcomes (4)

• Incidence of new-onset or reversible systolic left ventricular dysfunction

  Through study completion, an estimation of 6 months

• Changes of extravascular lung water measured by transpulmonary thermodilution

  Change from baseline extravascular lung water at 6 months

• Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution

  Change from baseline extravascular lung water at 6 months

• Correlation between the hemodynamic characteristics and 90-day mortality

  Up to 90th day after inclusion

Interventions

Transpulmonary thermodilution DEVICE

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 DEVICE

Daily echocardiography evaluation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SARS-Cov2 positive patients admitted to ICU and monitored by transpulmonary thermodilution system will be included.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Bicetre Hospital

Paris, Val-de-Marne, 94270, France

Location

Related Publications (13)

• 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.

  PMID: 32015507 BACKGROUND

• 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.

  PMID: 32031570 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

• 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.

  PMID: 32007143 BACKGROUND

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32201335 BACKGROUND

• 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.

  PMID: 32125452 BACKGROUND

• 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.

  PMID: 32105632 BACKGROUND

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 17221188 BACKGROUND

• 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.

  PMID: 23263578 BACKGROUND

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

  PMID: 28625165 BACKGROUND

• 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.

  PMID: 34074313 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Respiratory Distress Syndrome; Shock; Ventricular Dysfunction, Left; Edema

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Xavier Monnet MD. PhD.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 8, 2020
• Study Start: March 13, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

FR (1)