Mathematical Coupling of Data in Transpulmonary Thermodilution

NCT02239705 | Unknown DMC

• 1 other identifier: A02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Trans pulmonary thermodilution; Hemodynamic

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Fluid challenge

Patients whose clinical conditions require bolus of fluids infusion to correct blood pressure and cardiac output

Inotropic infusion

Patient whose clinical conditions require inotropic agents infusion to correct blood pressure and cardiac output

Eligibility Criteria

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

Study Population

Critically ill patients

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• age less than 18

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Ospedali Riuniti

Foggia, FG, 70100, Italy

Location

Related Links

• Speciality school of anesthesia of University of Foggia

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Dambrosio, Medic

  University of Foggia

  STUDY CHAIR

• Livio Tullo, Medic

  University of Foggia

  STUDY DIRECTOR

• Alberto Sciusco, medic

  University of Foggia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Sciusco, Doctor

CONTACT

0039 329 0408320; albertsciusc@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

IT (1)