Central Venous and Abdominal Pressures and the Inferior Vena Cava

NCT01840670 | Unknown

• 1 other identifier: UCSC-123-FC
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovolemia

Keywords

Inferior Vena Cava; Central Venous Pressure; Abdominal Pressure

Outcome Measures

Primary Outcomes (1)

• The eccentricity of inferior vena cava transverse sections

  The ratio R between the minimum and maximum diameters of inferior vena cava transverse sections at four different levels

  Baseline and after forty minutes

Secondary Outcomes (1)

• Blood velocity

  Baseline and after forty minutes

Interventions

Rapid fluid load test DRUG

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

Also known as: VoluvenR

Eligibility Criteria

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

Study Population

Patients undergoing cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Rome, Rome, 00168, Italy

RECRUITING

Related Publications (14)

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  PMID: 2386120 BACKGROUND

• Dipti A, Soucy Z, Surana A, Chandra S. Role of inferior vena cava diameter in assessment of volume status: a meta-analysis. Am J Emerg Med. 2012 Oct;30(8):1414-1419.e1. doi: 10.1016/j.ajem.2011.10.017. Epub 2012 Jan 4.

  PMID: 22221934 BACKGROUND

• Arthur ME, Landolfo C, Wade M, Castresana MR. Inferior vena cava diameter (IVCD) measured with transesophageal echocardiography (TEE) can be used to derive the central venous pressure (CVP) in anesthetized mechanically ventilated patients. Echocardiography. 2009 Feb;26(2):140-9. doi: 10.1111/j.1540-8175.2008.00772.x. Epub 2008 Nov 24.

  PMID: 19054047 BACKGROUND

• Lorsomradee S, Lorsomradee S, Cromheecke S, ten Broecke PW, De Hert SG. Inferior vena cava diameter and central venous pressure correlation during cardiac surgery. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):492-6. doi: 10.1053/j.jvca.2006.09.009. Epub 2006 Dec 22.

  PMID: 17678773 BACKGROUND

• Barbier C, Loubieres Y, Schmit C, Hayon J, Ricome JL, Jardin F, Vieillard-Baron A. Respiratory changes in inferior vena cava diameter are helpful in predicting fluid responsiveness in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1740-6. doi: 10.1007/s00134-004-2259-8. Epub 2004 Mar 18.

  PMID: 15034650 BACKGROUND

• Goldhammer E, Mesnick N, Abinader EG, Sagiv M. Dilated inferior vena cava: a common echocardiographic finding in highly trained elite athletes. J Am Soc Echocardiogr. 1999 Nov;12(11):988-93. doi: 10.1016/s0894-7317(99)70153-7.

  PMID: 10552361 BACKGROUND

• Kimura BJ, Dalugdugan R, Gilcrease GW 3rd, Phan JN, Showalter BK, Wolfson T. The effect of breathing manner on inferior vena caval diameter. Eur J Echocardiogr. 2011 Feb;12(2):120-3. doi: 10.1093/ejechocard/jeq157. Epub 2010 Oct 27.

  PMID: 20980326 BACKGROUND

• Ho JD, Dawes DM, Moore JC, Caroon LV, Miner JR. Effect of position and weight force on inferior vena cava diameter--implications for arrest-related death. Forensic Sci Int. 2011 Oct 10;212(1-3):256-9. doi: 10.1016/j.forsciint.2011.07.001. Epub 2011 Jul 27.

  PMID: 21798678 BACKGROUND

• Saul T, Lewiss RE, Langsfeld A, Radeos MS, Del Rios M. Inter-rater reliability of sonographic measurements of the inferior vena cava. J Emerg Med. 2012 May;42(5):600-5. doi: 10.1016/j.jemermed.2011.05.095. Epub 2012 Jan 12.

  PMID: 22244287 BACKGROUND

• Cavaliere F, Cina A, Biasucci D, Costa R, Soave M, Gargaruti R, Bonomo L, Proietti R. Sonographic assessment of abdominal vein dimensional and hemodynamic changes induced in human volunteers by a model of abdominal hypertension. Crit Care Med. 2011 Feb;39(2):344-8. doi: 10.1097/CCM.0b013e3181ffe0d2.

  PMID: 21099427 BACKGROUND

• Moreno FL, Hagan AD, Holmen JR, Pryor TA, Strickland RD, Castle CH. Evaluation of size and dynamics of the inferior vena cava as an index of right-sided cardiac function. Am J Cardiol. 1984 Feb 1;53(4):579-85. doi: 10.1016/0002-9149(84)90034-1.

  PMID: 6695787 BACKGROUND

• Willenberg T, Clemens R, Haegeli LM, Amann-Vesti B, Baumgartner I, Husmann M. The influence of abdominal pressure on lower extremity venous pressure and hemodynamics: a human in-vivo model simulating the effect of abdominal obesity. Eur J Vasc Endovasc Surg. 2011 Jun;41(6):849-55. doi: 10.1016/j.ejvs.2011.02.015. Epub 2011 Mar 16.

  PMID: 21414818 BACKGROUND

• Murphy EH, Johnson ED, Arko FR. Evaluation of wall motion and dynamic geometry of the inferior vena cava using intravascular ultrasound: implications for future device design. J Endovasc Ther. 2008 Jun;15(3):349-55. doi: 10.1583/08-2424.1.

  PMID: 18540710 BACKGROUND

• Murphy EH, Arko FR, Trimmer CK, Phangureh VS, Fogarty TJ, Zarins CK. Volume associated dynamic geometry and spatial orientation of the inferior vena cava. J Vasc Surg. 2009 Oct;50(4):835-42; discussion 842-3. doi: 10.1016/j.jvs.2009.05.012. Epub 2009 Aug 6.

  PMID: 19660896 BACKGROUND

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Franco Cavaliere, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Cavaliere, Prof.

CONTACT

+39 06 30154386; f.cavaliere@rm.unicatt.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 26, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

IT (1)