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Central Venous and Abdominal Pressures and the Inferior Vena Cava

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ClinicalTrials.gov Identifier: NCT01840670
Recruitment Status : Unknown
Verified August 2013 by Franco Cavaliere, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : April 26, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Franco Cavaliere, Catholic University of the Sacred Heart

Brief Summary:

The elliptic shape of inferior vena cava (IVC) sections, while hindering the ultrasound measurement of IVC diameter, may provide a useful tool to estimate central venous pressure (CVP). Hypothetically, the higher is CVP and more the ratio R between minimum and maximum diameters approximates 1. The purpose of this study is to determine R values in four different sections before and after a fluid load test, in order to evaluate if R is affected by the test and at which level the variation is larger.

The secondary endpoint is to search for the parameter best predictive of the positivity of the fluid load test among IVC minimum and maximum diameters, eccentricity, section area, and blood velocity at the level that presented the largest variations after the fluid load.


Condition or disease Intervention/treatment
Hypovolemia Drug: Rapid fluid load test

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Central Venous and Abdominal Pressures on the Inferior Vena Cava Shape and Size
Study Start Date : May 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Intervention Details:
  • Drug: Rapid fluid load test
    The test will be performed by infusing 250-300 mL/m2 Body Surface Area of 6% hydroxyethyl starch 6% 130/0.4 (VoluvenR) in 30 minutes
    Other Name: VoluvenR


Primary Outcome Measures :
  1. The eccentricity of inferior vena cava transverse sections [ Time Frame: Baseline and after forty minutes ]
    The ratio R between the minimum and maximum diameters of inferior vena cava transverse sections at four different levels


Secondary Outcome Measures :
  1. Blood velocity [ Time Frame: Baseline and after forty minutes ]
    Maximum and average blood velocity measured immediately below the confluence of the hepatic veins by Doppler provided that the angle of insonation is 60° or less.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cardiac surgery
Criteria

Inclusion Criteria:

  • the need determined by the attending physician to perform a rapid fluid load test to guide infusions
  • a condition of adequate sedation and good adaptation to mechanical ventilation
  • the presence of an arterial catheter and a catheter in the pulmonary artery

Exclusion Criteria:

  • obesity (BMI> 30 kg/m2)
  • age <18 years
  • women of childbearing age
  • tricuspid insufficiency
  • hemodynamically significant right ventricular failure
  • bleeding from the surgical drains greater than 150 mL in the hour preceding the enrollment
  • history of allergy to colloids
  • administration of more than 1000 mL of hydroxyethyl starch in the last 24 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840670


Contacts
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Contact: Franco Cavaliere, Prof. +39 06 30154386 f.cavaliere@rm.unicatt.it

Locations
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Italy
Catholic University of the Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Franco Cavaliere, Prof.    +39 06 30154386    f.cavaliere@rm.unicatt.it   
Sub-Investigator: Riccardo Gargaruti, MD         
Principal Investigator: Alessandro Cina, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Franco Cavaliere, MD Catholic University of the Sacred Heart

Publications:

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Responsible Party: Franco Cavaliere, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01840670     History of Changes
Other Study ID Numbers: UCSC-123-FC
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013
Keywords provided by Franco Cavaliere, Catholic University of the Sacred Heart:
Inferior Vena Cava
Central Venous Pressure
Abdominal Pressure
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes