Mathematical Coupling of Data in Transpulmonary Thermodilution

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether cardiac output (CO) and global end diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are mathematically coupled during the infusion of fluid or inotropic agents in critically ill patients.

Detailed Description
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Some fundamental questions remain unanswered about the mathematical analysis of the thermodilution curve and the physiological significance of the Global End Diastolic Volume ( GEDV ) . The mathematical derivation of the Global End Diastolic Volume (GEDV) is intimately linked with the Cardiac Output (CO), because EV1000, to calculate the GEDV, uses a formula in which the CO is the term flow  for both the calculations of Volume Thermal Intra Thoracic (ITTV) and Lung Thermal volume (PTV) . The clinical validation of GEDV as an index of preload has been substantially based on measuring changes in GEDV and CO in response to the Fluid Challenge only in patients volume responsive. In this scenario, GEDV and CO may show a close correlation only on the basis of their mathematical derivation.

Official Title
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Mathematical Coupling of Data Between Global-End Diastolic Volume Index and Cardiac Index Calculated by Edwards EV1000

Conditions
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Critical Illness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient admitted in the Intensive Care Department patient monitored by EV1000 trans pulmonary device Systolic blood pressure (SBP) less than 90 mm Hg or SBP Drop ≥ 40 mm Hg of normal decision by 1 expert intensivist physician to initiate fluid resuscitation hospital protocol or therapeutic infusion of vasopressor agent Exclusion Criteria: pregnancy age less than 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluid challenge<br>Patients whose clinical conditions require bolus of fluids infusion to correct blood pressure and cardiac output | |
| Inotropic infusion<br>Patient whose clinical conditions require inotropic agents infusion to correct blood pressure and cardiac output | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiac Output | To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, cardiac output will be assessed before and after 20 minutes starting infusion. | Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents | 
| Change in Global end diastolic volume | To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, global end diastolic volume will be assessed before and after 20 minutes starting infusion. | Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents | 
| Change Left ventricular volume | To evaluate the change in cardiac function after therapeutic, life-saving fluid resuscitation or vasopressor agent infusion, Left ventricular volume measurement with echocardiography will be evaluated before and after 20 minutes starting infusion. | Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents | 
| Change Right ventricular volume | To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, Right Ventricular Volume measurement with echocardiography will be assessed before and after 20 minutes starting infusion. | Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trans pulmonary thermodilution, Hemodynamic