HypovolemiaNCT01840670
Central Venous and Abdominal Pressures and the Inferior Vena Cava
An observational study of Hypovolemia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Rapid fluid load test
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of the Sacred Heart
Rome, Rome, 00168
Franco Cavaliere, Prof., +39 06 30154386, f.cavaliere@rm.unicatt.it
Riccardo Gargaruti, MD
About this study
Official title: Influence of Central Venous and Abdominal Pressures on the Inferior Vena Cava Shape and Size
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.
Read the detailed description
The study will be carried out during the first 6 hours after the end of cardiac surgery when patients are mechanically ventilated and sedated with propofol and remifentanil to achieve a Ramsey sedation score of 3-4. The following four steps will be carried out:
- A baseline hemodynamic and ultrasound assessment with the head of the bed positioned at 30 °.
- The measurement of abdominal pressure with the head of the bed placed in a horizontal position for 3 minutes.
- A rapid fluid load test with the head of the bed raised again to be 30°. 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 and will be considered positive if the cardiac index increases by at least 15% above the baseline value.
- A second hemodynamic and ultrasound assessment with the head of the bed positioned at 30 °.
Hemodynamic evaluation The hemodynamic assessment will be run out by evaluating heart rate, systemic arterial and pulmonary pressures, central venous pressure, and pulmonary wedge pressure. Cardiac output will be measured by the thermodilution technique; the mean of three measures will be taken; then cardiac index will be calculated by dividing the cardiac output by the body surface area.
Ultrasound measurements
IVC maximum and minimum diameters (which will be defined as anteroposterior and lateral) will be measured at the end of inspiration and of expiration at four levels:
- 1 cm after the confluence of the iliac veins
- At the confluence of the renal veins
- Immediately below the confluence of the hepatic veins
- Immediately above the confluence of the hepatic veins (also in long axis)
At level 3 maximum and average blood velocity will be measured by Doppler provided that the angle of insonation is 60° or less.
At each level, we will compute the ratio R between the anteroposterior and lateral diameters (eccentricity) and the sectional area, calculated with the formula for the ellipse.
Statistical analysis The data obtained will be presented as mean (standard deviation). Statistical analysis will be performed with ANOVA for repeated measures and post-hoc comparisons with Student Newman Keuls test. ROC (Receiver Operating Characteristic) curves will be calculated to test the predictivity of a positive fluid load test by the aforementioned parameters; the analysis will be performed at the level at which each parameter shows the largest variations after the load test.
The a priori power analysis was performed on the primary endpoint, i.e. on changes of R in relation to IVC levels and fluid volume test with the program Gpower (17). The analysis was carried out on ANOVA with a 4 x 2 design by assuming an α error of 0.05, a power of 1-β of 0.95, and an f of 0.40, which corresponded to a large-size effect. The index f is a standardized measure of the effect size and is equal to the minimum difference considered clinically relevant divided by the standard deviation in the population. Since, the standard deviation of R was 0.1 in a previous study on healthy volunteers, an f value of 0.4 corresponded to a minimal difference of 0.04 between R values. On this basis, we obtained 112 determinations over all groups of the design, which corresponded to a sample of 14 patients (112/8=14); such value was increased by 10%, and the final sample of 16 patients was obtained.
- Conditions
- Hypovolemia
- Being tested
- Rapid fluid load test
- Keywords
- Inferior Vena Cava, Central Venous Pressure, Abdominal Pressure
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid fluid load testDrug
Also called VoluvenR
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after forty minutes
Secondary outcomes (1)
Blood velocity
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.
Measured: Baseline and after forty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Cavaliere, Catholic University of the Sacred Heart
- Investigators
- Franco Cavaliere, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840670
- Sponsor's protocol ID
- UCSC-123-FC
- Status last verified
- Aug 2013
- First submitted
- 17 Apr 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.
PubMed 2386120Dipti 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.
PubMed 22221934Arthur 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.
PubMed 19054047Lorsomradee 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.
PubMed 17678773Barbier 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.
PubMed 15034650Goldhammer 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.
PubMed 10552361Kimura 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.
PubMed 20980326Ho 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.
PubMed 21798678Saul 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.
PubMed 22244287Cavaliere 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.
PubMed 21099427Moreno 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.
PubMed 6695787Willenberg 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.
PubMed 21414818Murphy 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.
PubMed 18540710Murphy 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.
PubMed 19660896
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Central Venous and Abdominal Pressures on the Inferior Vena Cava Shape and Size
- ClinicalTrials.gov ID
- NCT01840670
- Acronym / sponsor ID
- UCSC-123-FC
- Conditions
- Hypovolemia
- Keywords
- Inferior Vena Cava, Central Venous Pressure, Abdominal Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be carried out during the first 6 hours after the end of cardiac surgery when patients are mechanically ventilated and sedated with propofol and remifentanil to achieve a Ramsey sedation score of 3-4. The following four steps will be carried out:
- A baseline hemodynamic and ultrasound assessment with the head of the bed positioned at 30 °.
- The measurement of abdominal pressure with the head of the bed placed in a horizontal position for 3 minutes.
- A rapid fluid load test with the head of the bed raised again to be 30°. 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 and will be considered positive if the cardiac index increases by at least 15% above the baseline value.
- A second hemodynamic and ultrasound assessment with the head of the bed positioned at 30 °.
Hemodynamic evaluation The hemodynamic assessment will be run out by evaluating heart rate, systemic arterial and pulmonary pressures, central venous pressure, and pulmonary wedge pressure. Cardiac output will be measured by the thermodilution technique; the mean of three measures will be taken; then cardiac index will be calculated by dividing the cardiac output by the body surface area.
Ultrasound measurements
IVC maximum and minimum diameters (which will be defined as anteroposterior and lateral) will be measured at the end of inspiration and of expiration at four levels:
- 1 cm after the confluence of the iliac veins
- At the confluence of the renal veins
- Immediately below the confluence of the hepatic veins
- Immediately above the confluence of the hepatic veins (also in long axis)
At level 3 maximum and average blood velocity will be measured by Doppler provided that the angle of insonation is 60° or less.
At each level, we will compute the ratio R between the anteroposterior and lateral diameters (eccentricity) and the sectional area, calculated with the formula for the ellipse.
Statistical analysis The data obtained will be presented as mean (standard deviation). Statistical analysis will be performed with ANOVA for repeated measures and post-hoc comparisons with Student Newman Keuls test. ROC (Receiver Operating Characteristic) curves will be calculated to test the predictivity of a positive fluid load test by the aforementioned parameters; the analysis will be performed at the level at which each parameter shows the largest variations after the load test.
The a priori power analysis was performed on the primary endpoint, i.e. on changes of R in relation to IVC levels and fluid volume test with the program Gpower (17). The analysis was carried out on ANOVA with a 4 x 2 design by assuming an α error of 0.05, a power of 1-β of 0.95, and an f of 0.40, which corresponded to a large-size effect. The index f is a standardized measure of the effect size and is equal to the minimum difference considered clinically relevant divided by the standard deviation in the population. Since, the standard deviation of R was 0.1 in a previous study on healthy volunteers, an f value of 0.4 corresponded to a minimal difference of 0.04 between R values. On this basis, we obtained 112 determinations over all groups of the design, which corresponded to a sample of 14 patients (112/8=14); such value was increased by 10%, and the final sample of 16 patients was obtained.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- obesity (BMI> 30 kg/m2)
- age <18 years
- women of childbearing age
- tricuspid insufficiency
- hemodynamically significant right ventricular failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid fluid load testAlso: VoluvenRThe 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 | Drug | – |
Primary outcome
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
1 secondary outcome
Blood velocity
Time frame: Baseline and after forty minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Background: PubMed 2386120Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.
- Background: PubMed 22221934Dipti 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.
- Background: PubMed 19054047Arthur 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.
- Background: PubMed 17678773Lorsomradee 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.
- Background: PubMed 15034650Barbier 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.
- Background: PubMed 10552361Goldhammer 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.
- Background: PubMed 20980326Kimura 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.
- Background: PubMed 21798678Ho 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.
- Background: PubMed 22244287Saul 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.
- Background: PubMed 21099427Cavaliere 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.
- Background: PubMed 6695787Moreno 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.
- Background: PubMed 21414818Willenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Cavaliere, MD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Cavaliere, Prof. (+39 06 30154386, f.cavaliere@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eccentricity of inferior vena cava transverse sections (time frame: Baseline and after forty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840670, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.