Mathematical Coupling of Data in Transpulmonary Thermodilution

• Conditions: Critical Illness

• Registration Number: NCT02239705
• Lead Sponsor: University of Foggia

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.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-15
• Last Update Posted: 2014-09-15
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change Left ventricular volume	Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents	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.
Change in Global end diastolic volume	Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents	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.
Change in Cardiac Output	Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents	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.
Change Right ventricular volume	Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents	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.

Trial Locations

Locations (1)

Ospedali Riuniti; 🇮🇹 Foggia, FG, Italy