Clinical trial NCT02239705: Mathematical Coupling of Data in Transpulmonary Thermodilution
Official title: Mathematical Coupling of Data Between Global-End Diastolic Volume Index and Cardiac Index Calculated by Edwards EV1000
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Keywords: Trans pulmonary thermodilution
Hemodynamic
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cardiac Output
timeFrame: Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
measure: Change in Global end diastolic volume
timeFrame: Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
measure: Change Left ventricular volume
timeFrame: Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
measure: Change Right ventricular volume
timeFrame: Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: FG
Study officials:
affiliation: University of Foggia
name: Michele Dambrosio, Medic
role: STUDY_CHAIR
affiliation: University of Foggia
name: Livio Tullo, Medic
role: STUDY_DIRECTOR
affiliation: University of Foggia
name: Alberto Sciusco, medic
role: PRINCIPAL_INVESTIGATOR
References: