Mathematical Coupling of Data in Transpulmonary Thermodilution

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02239705
• Other study ID #: A02
• Status: Not yet recruiting
• Phase: N/A
• First received: September 10, 2014
• Last updated: September 11, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: University of Foggia
• Contact: Alberto Sciusco, Doctor
• Phone: 0039 329 0408320
• Email: albertsciusc[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Foggia	FG

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes

External Links

•   Speciality school of anesthesia of University of Foggia