Perioperative Fluid ManagementTHRIVE-CARDNCT07305051
Study Of Ultrasound Windows For Measuring Inferior Vena Cava Changes Before Cardiac Surgery
An observational study of Perioperative Fluid Management and Hemodynamic Monitoring, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This research study will compare two ultrasound methods for assessing the inferior vena cava (IVC), a major vein that reflects intravascular fluid status and cardiac function before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Fluid Management, Hemodynamic Monitoring, Inferior Vena Cava Collapsibility Index
- How many people
- 283 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult patients scheduled to undergo elective cardiac surgery at Sunnybrook Health Sciences Centre. Eligible participants will be spontaneously breathing and able to lie supine during ultrasound assessment. The study will include male and female patients aged eighteen years or older, with no upper age limit. Exclusion criteria focus on conditions that impair accurate visualization of the inferior vena cava, including right heart failure, significant tricuspid regurgitation, portal hypertension, end-stage renal disease, obstructive dressings, or inadequate acoustic windows despite optimization maneuvers. This population reflects typical perioperative cardiac surgery patients in whom reliable non-invasive assessment of fluid status is clinically relevant.
Who may be able to join
- Adults aged eighteen years or older
- Scheduled to undergo cardiac surgery at Sunnybrook Health Sciences Centre
- Spontaneously breathing at the time of ultrasound assessment
- Able to lie supine for image acquisition
- Able to provide written informed consent
Who cannot join
- Inability to lie supine
- Known right heart failure
- Moderate to severe tricuspid regurgitation
- Portal hypertension
- End-stage renal disease
- Presence of abdominal dressings or conditions that preclude transhepatic imaging
- Poor acoustic windows that prevent adequate measurement from either the subcostal or transhepatic view, despite standard optimization techniques (positioning, breathing coaching, depth and gain adjustment, probe angulation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Lilia Kaustov, MSC, PhD, 416-967-8587, Lilia.Kaustov@sunnybrook.ca
About this study
Official title: Comparison of Transhepatic and Subcostal Views for Assessing Inferior Vena Cava Diameter Variation in Cardiac Surgery Patients
This research study will compare two ultrasound methods for assessing the inferior vena cava (IVC), a major vein that reflects intravascular fluid status and cardiac function before and after surgery. The standard method uses a subcostal ultrasound view obtained below the breastbone, but this approach may be limited in patients with obesity, surgical dressings, or postoperative discomfort. An alternative approach, the transhepatic view, uses the liver as an acoustic window and may provide improved feasibility in these situations.
The study will evaluate whether the transhepatic view provides measurements comparable to the standard subcostal view and whether operators with different levels of ultrasound experience obtain consistent results using both methods. Adult patients who are awake and scheduled for cardiac surgery at Sunnybrook Health Sciences Centre will undergo a brief ultrasound examination before surgery. The scan takes less than 10 minutes, involves no discomfort, and does not alter clinical care. This is a minimal-risk observational study with no therapeutic interventions. Participation is voluntary, and all personal health information will remain confidential. Findings may inform future approaches to ultrasound-guided assessment and training in perioperative care.
Read the detailed description
Respiratory variation in inferior vena cava (IVC) diameter is a widely accepted non-invasive marker of intravascular volume status and fluid responsiveness, particularly in spontaneously breathing patients. Among transthoracic echocardiographic windows, this variation is most commonly assessed using the subcostal (SC) view, which is considered the clinical reference standard due to its direct acoustic pathway and extensive validation in research and clinical practice. The physiologic basis for this measure is strongest in the context of spontaneous respiration, where negative intrathoracic pressure significantly influences venous return dynamics. For this reason, the study population is limited to spontaneously breathing patients to ensure physiologic consistency and interpretive validity.
The SC view, however, may be limited by factors such as body habitus, postoperative dressings, or an obstructed subxiphoid window. The transhepatic (TH) view has been proposed as a complementary or alternative approach, providing an oblique acoustic window through the liver that facilitates visualization of the IVC long axis. Several observational studies have reported strong correlation and agreement between TH and SC measurements of IVC diameter and collapsibility, including in both spontaneously breathing and mechanically ventilated patients. Despite these promising findings, prior studies have been constrained by small sample sizes, heterogeneous methodologies, and limited assessment of reproducibility-particularly across operators with different levels of ultrasound experience. These gaps underscore the need for a larger, methodologically rigorous validation study.
The primary objective of this prospective, single-center observational study is to evaluate agreement between the SC and TH views using methodological standards aligned with diagnostic accuracy frameworks such as QUADAS-2, in a larger cohort of patients scheduled for cardiac surgery. The secondary objective is to assess interrater reliability of TH and SC IVC measurements obtained by novice and expert sonographers. The results are intended to strengthen the evidence base supporting the use of the transhepatic view in perioperative care and to inform future training, competency assessment, and quality-assurance processes in point-of-care ultrasound.
- Conditions
- Perioperative Fluid Management, Hemodynamic Monitoring, Inferior Vena Cava Collapsibility Index, Cardiac Surgery Patients
- Keywords
- point-of-care ultrasound (POCUS), Transhepatic view, Subcostal view, Inferior vena cava (IVC), Echocardiography, Ultrasound imaging, Central venous assessment, Cardiac surgery, Fluid status assessment, Interrater reliability, Sunnybrook Health Sciences Centre, Adult patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Cardiac Surgery Patients | This group includes adult patients (Age ≥ 18) who are awake, spontaneously breathing, and scheduled to undergo cardiac surgery at Sunnybrook Health Sciences Centre. They must also be able to lie supine and provide informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement for collapsibility index (cIVC) between transhepatic and subcostal views
Outcome Metric: Intraclass correlation coefficient (ICC) for the collapsibility index (unitless).
Rationale: To determine agreement between transhepatic and subcostal cIVC measurements.
Measured: Preoperative period, within twenty-four to forty-eight hours before cardiac surgery.
Secondary outcomes (3)
Inter-rater reliability for transhepatic collapsibility index (cIVC)
Metric: ICC(2,1) for cIVC (unitless).
Rationale: To assess reproducibility between novice and expert sonographers.
Measured: Preoperative period, during the same imaging session.
Agreement for IVC maximum diameter (IVCmax)
Metrics: ICC for IVC maximum diameter (millimetres). Rationale: To determine whether transhepatic and subcostal measurements of IVC maximum diameter demonstrate sufficient agreement to support interchangeable use of the two ultrasound views for this parameter.
Measured: Preoperative period, during the same imaging session.
Bland-Altman analysis for IVC diameter ratio (IVCmax:IVCmin)
Outcome Metric:
Bland-Altman bias and limits of agreement for the IVC diameter ratio (unitless).
Rationale:
To assess systematic bias and variability in the ratio of IVC maximum to minimum diameter across the two ultrasound views, offering an additional perspective on agreement in dynamic IVC behavior.
Measured: Preoperative period, during the same imaging session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Perioperative Fluid ManagementStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 283 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacobo Moreno Garijo, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305051
- Sponsor's protocol ID
- 6762
- Acronym
- THRIVE-CARD
- Status last verified
- Jul 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results (including ultrasound measurements and basic demographic variables) will be made available to qualified researchers upon reasonable request to the Principal Investigator, following publication of the primary manuscript. Data will be stored on secure institutional servers at Sunnybrook Research Institute.
Publications
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PubMed 843571Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
PubMed 27330520McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995 Aug;4(4):293-307. doi: 10.1007/BF01593882.
PubMed 7550178Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, Leeflang MM, Sterne JA, Bossuyt PM; QUADAS-2 Group. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011 Oct 18;155(8):529-36. doi: 10.7326/0003-4819-155-8-201110180-00009.
PubMed 22007046Blehar DJ, Barton B, Gaspari RJ. Learning curves in emergency ultrasound education. Acad Emerg Med. 2015 May;22(5):574-82. doi: 10.1111/acem.12653. Epub 2015 Apr 22.
PubMed 25903780Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available.
PubMed 23711341Sites BD, Spence BC, Gallagher JD, Wiley CW, Bertrand ML, Blike GT. Characterizing novice behavior associated with learning ultrasound-guided peripheral regional anesthesia. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):107-15. doi: 10.1016/j.rapm.2006.11.006.
PubMed 17350520Croskerry P. The importance of cognitive errors in diagnosis and strategies to minimize them. Acad Med. 2003 Aug;78(8):775-80. doi: 10.1097/00001888-200308000-00003.
PubMed 12915363Sanfilippo F, La Via L, Dezio V, Santonocito C, Amelio P, Genoese G, Astuto M, Noto A. Assessment of the inferior vena cava collapsibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on healthy volunteers. Intensive Care Med Exp. 2023 Apr 3;11(1):15. doi: 10.1186/s40635-023-00505-7.
PubMed 37009935Sanfilippo F, La Via L, Dezio V, Amelio P, Genoese G, Franchi F, Messina A, Robba C, Noto A. Inferior vena cava distensibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on mechanically ventilated patients. Intensive Care Med Exp. 2023 Jul 10;11(1):40. doi: 10.1186/s40635-023-00529-z.
PubMed 37423948Hasanin A, Karam N, Mostafa M, Abdelnasser A, Hamimy W, Fouad AZ, Eladawy A, Lotfy A. THE ACCURACY OF INFERIOR VENA CAVA DISTENSIBILITY THROUGH THE TRANSHEPATIC APPROACH TO PREDICT FLUID RESPONSIVENESS IN PATIENTS WITH SEPTIC SHOCK AFTER EMERGENCY LAPAROTOMY. Shock. 2023 Oct 1;60(4):560-564. doi: 10.1097/SHK.0000000000002212. Epub 2023 Aug 23.
PubMed 37625114Bortolotti P, Colling D, Colas V, Voisin B, Dewavrin F, Poissy J, Girardie P, Kyheng M, Saulnier F, Favory R, Preau S. Respiratory changes of the inferior vena cava diameter predict fluid responsiveness in spontaneously breathing patients with cardiac arrhythmias. Ann Intensive Care. 2018 Aug 2;8(1):79. doi: 10.1186/s13613-018-0427-1.
PubMed 30073423Manzur-Sandoval D, Arteaga-Cardenas G, Gopar-Nieto R, Lazcano-Diaz E, Rojas-Velasco G. Correlation between transhepatic and subcostal inferior vena cava ultrasonographic images for evaluating fluid responsiveness after cardiac surgery. J Card Surg. 2022 Sep;37(9):2586-2591. doi: 10.1111/jocs.16696. Epub 2022 Jun 23.
PubMed 35735244Kelly N, Esteve R, Papadimos TJ, Sharpe RP, Keeney SA, DeQuevedo R, Portner M, Bahner DP, Stawicki SP. Clinician-performed ultrasound in hemodynamic and cardiac assessment: a synopsis of current indications and limitations. Eur J Trauma Emerg Surg. 2015 Oct;41(5):469-80. doi: 10.1007/s00068-014-0492-6. Epub 2015 Jan 8.
PubMed 26038013de Oliveira OH, Freitas FG, Ladeira RT, Fischer CH, Bafi AT, Azevedo LC, Machado FR. Comparison between respiratory changes in the inferior vena cava diameter and pulse pressure variation to predict fluid responsiveness in postoperative patients. J Crit Care. 2016 Aug;34:46-9. doi: 10.1016/j.jcrc.2016.03.017. Epub 2016 Mar 30.
PubMed 27288609
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transhepatic and Subcostal Views for Assessing Inferior Vena Cava Diameter Variation in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07305051
- Acronym / sponsor ID
- THRIVE-CARD / 6762
- Conditions
- Perioperative Fluid Management, Hemodynamic Monitoring, Inferior Vena Cava Collapsibility Index, Cardiac Surgery Patients
- Keywords
- point-of-care ultrasound (POCUS), Transhepatic view, Subcostal view, Inferior vena cava (IVC), Echocardiography, Ultrasound imaging, Central venous assessment, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 283 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Dec 2025 (actual)
- 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.
This research study will compare two ultrasound methods for assessing the inferior vena cava (IVC), a major vein that reflects intravascular fluid status and cardiac function before and after surgery. The standard method uses a subcostal ultrasound view obtained below the breastbone, but this approach may be limited in patients with obesity, surgical dressings, or postoperative discomfort. An alternative approach, the transhepatic view, uses the liver as an acoustic window and may provide improved feasibility in these situations.
The study will evaluate whether the transhepatic view provides measurements comparable to the standard subcostal view and whether operators with different levels of ultrasound experience obtain consistent results using both methods. Adult patients who are awake and scheduled for cardiac surgery at Sunnybrook Health Sciences Centre will undergo a brief ultrasound examination before surgery. The scan takes less than 10 minutes, involves no discomfort, and does not alter clinical care. This is a minimal-risk observational study with no therapeutic interventions. Participation is voluntary, and all personal health information will remain confidential. Findings may inform future approaches to ultrasound-guided assessment and training in perioperative care.
Detailed description
Respiratory variation in inferior vena cava (IVC) diameter is a widely accepted non-invasive marker of intravascular volume status and fluid responsiveness, particularly in spontaneously breathing patients. Among transthoracic echocardiographic windows, this variation is most commonly assessed using the subcostal (SC) view, which is considered the clinical reference standard due to its direct acoustic pathway and extensive validation in research and clinical practice. The physiologic basis for this measure is strongest in the context of spontaneous respiration, where negative intrathoracic pressure significantly influences venous return dynamics. For this reason, the study population is limited to spontaneously breathing patients to ensure physiologic consistency and interpretive validity.
The SC view, however, may be limited by factors such as body habitus, postoperative dressings, or an obstructed subxiphoid window. The transhepatic (TH) view has been proposed as a complementary or alternative approach, providing an oblique acoustic window through the liver that facilitates visualization of the IVC long axis. Several observational studies have reported strong correlation and agreement between TH and SC measurements of IVC diameter and collapsibility, including in both spontaneously breathing and mechanically ventilated patients. Despite these promising findings, prior studies have been constrained by small sample sizes, heterogeneous methodologies, and limited assessment of reproducibility-particularly across operators with different levels of ultrasound experience. These gaps underscore the need for a larger, methodologically rigorous validation study.
The primary objective of this prospective, single-center observational study is to evaluate agreement between the SC and TH views using methodological standards aligned with diagnostic accuracy frameworks such as QUADAS-2, in a larger cohort of patients scheduled for cardiac surgery. The secondary objective is to assess interrater reliability of TH and SC IVC measurements obtained by novice and expert sonographers. The results are intended to strengthen the evidence base supporting the use of the transhepatic view in perioperative care and to inform future training, competency assessment, and quality-assurance processes in point-of-care ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Cardiac Surgery Patients | – | –This group includes adult patients (Age ≥ 18) who are awake, spontaneously breathing, and scheduled to undergo cardiac surgery at Sunnybrook Health Sciences Centre. They must also be able to lie supine and provide informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients scheduled to undergo elective cardiac surgery at Sunnybrook Health Sciences Centre. Eligible participants will be spontaneously breathing and able to lie supine during ultrasound assessment. The study will include male and female patients aged eighteen years or older, with no upper age limit. Exclusion criteria focus on conditions that impair accurate visualization of the inferior vena cava, including right heart failure, significant tricuspid regurgitation, portal hypertension, end-stage renal disease, obstructive dressings, or inadequate acoustic windows despite optimization maneuvers. This population reflects typical perioperative cardiac surgery patients in whom reliable non-invasive assessment of fluid status is clinically relevant.
Key inclusion criteria (5 listed)
- Adults aged eighteen years or older
- Scheduled to undergo cardiac surgery at Sunnybrook Health Sciences Centre
- Spontaneously breathing at the time of ultrasound assessment
- Able to lie supine for image acquisition
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Inability to lie supine
- Known right heart failure
- Moderate to severe tricuspid regurgitation
- Portal hypertension
- End-stage renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement for collapsibility index (cIVC) between transhepatic and subcostal views
Time frame: Preoperative period, within twenty-four to forty-eight hours before cardiac surgery.
Outcome Metric: Intraclass correlation coefficient (ICC) for the collapsibility index (unitless). Rationale: To determine agreement between transhepatic and subcostal cIVC measurements.
3 secondary outcomes
Inter-rater reliability for transhepatic collapsibility index (cIVC)
Time frame: Preoperative period, during the same imaging session.
Agreement for IVC maximum diameter (IVCmax)
Time frame: Preoperative period, during the same imaging session.
Bland-Altman analysis for IVC diameter ratio (IVCmax:IVCmin)
Time frame: Preoperative period, during the same imaging session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 843571Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- Background: PubMed 27330520Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
- Background: PubMed 7550178McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995 Aug;4(4):293-307. doi: 10.1007/BF01593882.
- Background: PubMed 22007046Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, Leeflang MM, Sterne JA, Bossuyt PM; QUADAS-2 Group. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011 Oct 18;155(8):529-36. doi: 10.7326/0003-4819-155-8-201110180-00009.
- Background: PubMed 25903780Blehar DJ, Barton B, Gaspari RJ. Learning curves in emergency ultrasound education. Acad Emerg Med. 2015 May;22(5):574-82. doi: 10.1111/acem.12653. Epub 2015 Apr 22.
- Background: PubMed 23711341Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available.
- Background: PubMed 17350520Sites BD, Spence BC, Gallagher JD, Wiley CW, Bertrand ML, Blike GT. Characterizing novice behavior associated with learning ultrasound-guided peripheral regional anesthesia. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):107-15. doi: 10.1016/j.rapm.2006.11.006.
- Background: PubMed 12915363Croskerry P. The importance of cognitive errors in diagnosis and strategies to minimize them. Acad Med. 2003 Aug;78(8):775-80. doi: 10.1097/00001888-200308000-00003.
- Background: PubMed 37009935Sanfilippo F, La Via L, Dezio V, Santonocito C, Amelio P, Genoese G, Astuto M, Noto A. Assessment of the inferior vena cava collapsibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on healthy volunteers. Intensive Care Med Exp. 2023 Apr 3;11(1):15. doi: 10.1186/s40635-023-00505-7.
- Background: PubMed 37423948Sanfilippo F, La Via L, Dezio V, Amelio P, Genoese G, Franchi F, Messina A, Robba C, Noto A. Inferior vena cava distensibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on mechanically ventilated patients. Intensive Care Med Exp. 2023 Jul 10;11(1):40. doi: 10.1186/s40635-023-00529-z.
- Background: PubMed 37625114Hasanin A, Karam N, Mostafa M, Abdelnasser A, Hamimy W, Fouad AZ, Eladawy A, Lotfy A. THE ACCURACY OF INFERIOR VENA CAVA DISTENSIBILITY THROUGH THE TRANSHEPATIC APPROACH TO PREDICT FLUID RESPONSIVENESS IN PATIENTS WITH SEPTIC SHOCK AFTER EMERGENCY LAPAROTOMY. Shock. 2023 Oct 1;60(4):560-564. doi: 10.1097/SHK.0000000000002212. Epub 2023 Aug 23.
- Background: PubMed 30073423Bortolotti P, Colling D, Colas V, Voisin B, Dewavrin F, Poissy J, Girardie P, Kyheng M, Saulnier F, Favory R, Preau S. Respiratory changes of the inferior vena cava diameter predict fluid responsiveness in spontaneously breathing patients with cardiac arrhythmias. Ann Intensive Care. 2018 Aug 2;8(1):79. doi: 10.1186/s13613-018-0427-1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results (including ultrasound measurements and basic demographic variables) will be made available to qualified researchers upon reasonable request to the Principal Investigator, following publication of the primary manuscript. Data will be stored on secure institutional servers at Sunnybrook Research Institute.
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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.
Jacobo Moreno Garijo, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
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 Perioperative Fluid Management and Hemodynamic Monitoring, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 Dec 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilia Kaustov, MSc, PhD (416-967-8587, Lilia.Kaustov@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement for collapsibility index (cIVC) between transhepatic and subcostal views (time frame: Preoperative period, within twenty-four to forty-eight hours before cardiac surgery.). 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 NCT07305051, which also lists 22 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 26 Dec 2025.