Septic ShocklvotvtiNCT07797751
This Study Compares Two Noninvasive Dynamic Tools: Lung Ultrasound and Transthoracic Echocardiography Using LVOT VTI. It Aims to Measure the Sensitivity and Specificity of LUS in Guiding Fluid Resuscitation and Early Detection of Fluid Responsiveness and to Prevent Volume Overload
An observational study of Septic Shock and Fluid Reponsiveness, run by Ain Shams University.
Trial summary
Reliability of the LVOT-VTI versus lung ultrasonography for early detection of fluid intolerance during fluid resuscitation of septic patients. Read more about this study
- Who is it for?
- Ages 18 hours and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock, Fluid Reponsiveness
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 30 Dec 2026
- 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 hours and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patient with septic shock applied by inclusion \& exclusion criteria .
Who may be able to join
- Adult patients aged ≥ 18 years with septic shock.
- Mean arterial pressure (MAP) <65 mmHg.
- Need fluid resuscitation.
Who cannot join
- Patient <18 years.
- Refusal of patient or relative to participate in the study.
- Other types of shock.
- Morbid obesity.
- Valvular heart disease including severe aortic and mitral stenosis) and (severe aortic and mitral regurgitation).
- 7.Patients with heart failure with preserved or reduced Ejection fraction. 8.Burn patients. 9.End stage renal disease with regular hemodialysis patient. 11.Patients with massive pleural effusion. 12. patients with septic cardiomyopathy. 13.patients with massive ascites. 14. patient on high positive end expiratory pressure or with acute respiratory distress syndrome (ARDS). 15. Patients with right ventricular failure \& pulmonary hypertension. 16. Patients with pneumonia and interstitial lung diseases. 17. Ventilated patients. 18. Poor echo window patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Lung Ultrasonography and Left Ventricular Outflow Tract Velocity Time Integral for Early Detection of Fluid Overload After Fluid Resuscitation in Septic Shock Patients
Reliability of the LVOT-VTI versus lung ultrasonography for early detection of fluid intolerance during fluid resuscitation of septic patients.
Read the detailed description
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral. To decrease the incidence of fluid accumulation syndrome.
- To assess the feasibility and time required for each imaging modality in guiding fluid resuscitation.
- Comparison of the time required for point-of-care lung ultrasound versus LVOT-VTI to guide fluid resuscitation decisions.
To assess the sensitivity and specificity of lung ultrasonography (B-Lines) in predicting fluid non responsiveness in septic shock patients
- Conditions
- Septic Shock, Fluid Reponsiveness
- Keywords
- Septic, fluid, response, ultrasound
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral versus lung ultrasound
Measured: 12 hours
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral ursus lung ultrasound.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walid Youssef Kamel, Associate Professor, Study director, AinShams universityHeba Mohamed El-Serwi, Professor, Study director, AinShams universityMarwa Mamdoud El-Far, Assistant Professor, Study director, AinShams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797751
- Sponsor's protocol ID
- MS932/2025
- Acronym
- lvotvti
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weigl W, Adamski J, Onichimowski D, Nowakowski P, Wagner B. Methods of assessing fluid responsiveness in septic shock patients: a narrative review. Anaesthesiol Intensive Ther. 2022;54(2):175-183. doi: 10.5114/ait.2022.115368.
PubMed 35413788Wang J, Zhou D, Gao Y, Wu Z, Wang X, Lv C. Effect of VTILVOT variation rate on the assessment of fluid responsiveness in septic shock patients. Medicine (Baltimore). 2020 Nov 20;99(47):e22702. doi: 10.1097/MD.0000000000022702.
PubMed 33217793Spathoulas K, Tsolaki V, Zakynthinos GE, Karelas D, Makris D, Zakynthinos E, Papanikolaou J. The Role of Left Ventricular Ejection Fraction and Left Ventricular Outflow Tract Velocity-Time Integral in Assessing Cardiovascular Impairment in Septic Shock. J Pers Med. 2022 Oct 29;12(11):1786. doi: 10.3390/jpm12111786.
PubMed 36579502Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
PubMed 28101605Qayyum S, Shahid K. Fluid Resuscitation in Septic Patients. Cureus. 2023 Aug 29;15(8):e44317. doi: 10.7759/cureus.44317. eCollection 2023 Aug.
PubMed 37779759Pfortmueller CA, Dabrowski W, Wise R, van Regenmortel N, Malbrain MLNG. Fluid accumulation syndrome in sepsis and septic shock: pathophysiology, relevance and treatment-a comprehensive review. Ann Intensive Care. 2024 Jul 20;14(1):115. doi: 10.1186/s13613-024-01336-9.
PubMed 39033219Meyhoff TS, Hjortrup PB, Wetterslev J, Sivapalan P, Laake JH, Cronhjort M, Jakob SM, Cecconi M, Nalos M, Ostermann M, Malbrain M, Pettila V, Moller MH, Kjaer MN, Lange T, Overgaard-Steensen C, Brand BA, Winther-Olesen M, White JO, Quist L, Westergaard B, Jonsson AB, Hjortso CJS, Meier N, Jensen TS, Engstrom J, Nebrich L, Andersen-Ranberg NC, Jensen JV, Joseph NA, Poulsen LM, Herlov LS, Solling CG, Pedersen SK, Knudsen KK, Straarup TS, Vang ML, Bundgaard H, Rasmussen BS, Aagaard SR, Hildebrandt T, Russell L, Bestle MH, Schonemann-Lund M, Brochner AC, Elvander CF, Hoffmann SKL, Rasmussen ML, Martin YK, Friberg FF, Seter H, Aslam TN, Adnoy S, Seidel P, Strand K, Johnstad B, Joelsson-Alm E, Christensen J, Ahlstedt C, Pfortmueller CA, Siegemund M, Greco M, Radej J, Kriz M, Gould DW, Rowan KM, Mouncey PR, Perner A; CLASSIC Trial Group. Restriction of Intravenous Fluid in ICU Patients with Septic Shock. N Engl J Med. 2022 Jun 30;386(26):2459-2470. doi: 10.1056/NEJMoa2202707. Epub 2022 Jun 17.
PubMed 35709019Messmer AS, Zingg C, Muller M, Gerber JL, Schefold JC, Pfortmueller CA. Fluid Overload and Mortality in Adult Critical Care Patients-A Systematic Review and Meta-Analysis of Observational Studies. Crit Care Med. 2020 Dec;48(12):1862-1870. doi: 10.1097/CCM.0000000000004617.
PubMed 33009098McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Marik P, Bellomo R. A rational approach to fluid therapy in sepsis. Br J Anaesth. 2016 Mar;116(3):339-49. doi: 10.1093/bja/aev349. Epub 2015 Oct 27.
PubMed 26507493Jalil BA, Cavallazzi R. Predicting fluid responsiveness: A review of literature and a guide for the clinician. Am J Emerg Med. 2018 Nov;36(11):2093-2102. doi: 10.1016/j.ajem.2018.08.037. Epub 2018 Aug 14.
PubMed 30122506Gil Cebrian J, Bello Camara MP, Diaz-Alersi R. APACHE II. Intensive Care Med. 1987;13(2):143. No abstract available.
PubMed 3106446Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Enghard P, Rademacher S, Nee J, Hasper D, Engert U, Jorres A, Kruse JM. Simplified lung ultrasound protocol shows excellent prediction of extravascular lung water in ventilated intensive care patients. Crit Care. 2015 Feb 6;19(1):36. doi: 10.1186/s13054-015-0756-5.
PubMed 25656060Beshara M, Bittner EA, Goffi A, Berra L, Chang MG. Nuts and bolts of lung ultrasound: utility, scanning techniques, protocols, and findings in common pathologies. Crit Care. 2024 Oct 7;28(1):328. doi: 10.1186/s13054-024-05102-y.
PubMed 39375782
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Lung Ultrasonography and Left Ventricular Outflow Tract Velocity Time Integral for Early Detection of Fluid Overload After Fluid Resuscitation in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT07797751
- Acronym / sponsor ID
- lvotvti / MS932/2025
- Conditions
- Septic Shock, Fluid Reponsiveness
- Keywords
- Septic, fluid, response, ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Sep 2026 (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.
Reliability of the LVOT-VTI versus lung ultrasonography for early detection of fluid intolerance during fluid resuscitation of septic patients.
Detailed description
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral. To decrease the incidence of fluid accumulation syndrome.
- To assess the feasibility and time required for each imaging modality in guiding fluid resuscitation.
- Comparison of the time required for point-of-care lung ultrasound versus LVOT-VTI to guide fluid resuscitation decisions.
To assess the sensitivity and specificity of lung ultrasonography (B-Lines) in predicting fluid non responsiveness in septic shock patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 hours and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient with septic shock applied by inclusion \& exclusion criteria .
Key inclusion criteria (3 listed)
- Adult patients aged ≥ 18 years with septic shock.
- Mean arterial pressure (MAP) <65 mmHg.
- Need fluid resuscitation.
Key exclusion criteria (6 listed)
- Patient <18 years.
- Refusal of patient or relative to participate in the study.
- Other types of shock.
- Morbid obesity.
- Valvular heart disease including severe aortic and mitral stenosis) and (severe aortic and mitral regurgitation).
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
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral versus lung ultrasound
Time frame: 12 hours
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral ursus lung ultrasound.
Time frame: 12 hours
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 1 Sep 2026.
- Background: PubMed 35413788Weigl W, Adamski J, Onichimowski D, Nowakowski P, Wagner B. Methods of assessing fluid responsiveness in septic shock patients: a narrative review. Anaesthesiol Intensive Ther. 2022;54(2):175-183. doi: 10.5114/ait.2022.115368.
- Background: PubMed 33217793Wang J, Zhou D, Gao Y, Wu Z, Wang X, Lv C. Effect of VTILVOT variation rate on the assessment of fluid responsiveness in septic shock patients. Medicine (Baltimore). 2020 Nov 20;99(47):e22702. doi: 10.1097/MD.0000000000022702.
- Background: PubMed 36579502Spathoulas K, Tsolaki V, Zakynthinos GE, Karelas D, Makris D, Zakynthinos E, Papanikolaou J. The Role of Left Ventricular Ejection Fraction and Left Ventricular Outflow Tract Velocity-Time Integral in Assessing Cardiovascular Impairment in Septic Shock. J Pers Med. 2022 Oct 29;12(11):1786. doi: 10.3390/jpm12111786.
- Background: PubMed 28101605Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
- Background: PubMed 37779759Qayyum S, Shahid K. Fluid Resuscitation in Septic Patients. Cureus. 2023 Aug 29;15(8):e44317. doi: 10.7759/cureus.44317. eCollection 2023 Aug.
- Background: PubMed 39033219Pfortmueller CA, Dabrowski W, Wise R, van Regenmortel N, Malbrain MLNG. Fluid accumulation syndrome in sepsis and septic shock: pathophysiology, relevance and treatment-a comprehensive review. Ann Intensive Care. 2024 Jul 20;14(1):115. doi: 10.1186/s13613-024-01336-9.
- Background: PubMed 35709019Meyhoff TS, Hjortrup PB, Wetterslev J, Sivapalan P, Laake JH, Cronhjort M, Jakob SM, Cecconi M, Nalos M, Ostermann M, Malbrain M, Pettila V, Moller MH, Kjaer MN, Lange T, Overgaard-Steensen C, Brand BA, Winther-Olesen M, White JO, Quist L, Westergaard B, Jonsson AB, Hjortso CJS, Meier N, Jensen TS, Engstrom J, Nebrich L, Andersen-Ranberg NC, Jensen JV, Joseph NA, Poulsen LM, Herlov LS, Solling CG, Pedersen SK, Knudsen KK, Straarup TS, Vang ML, Bundgaard H, Rasmussen BS, Aagaard SR, Hildebrandt T, Russell L, Bestle MH, Schonemann-Lund M, Brochner AC, Elvander CF, Hoffmann SKL, Rasmussen ML, Martin YK, Friberg FF, Seter H, Aslam TN, Adnoy S, Seidel P, Strand K, Johnstad B, Joelsson-Alm E, Christensen J, Ahlstedt C, Pfortmueller CA, Siegemund M, Greco M, Radej J, Kriz M, Gould DW, Rowan KM, Mouncey PR, Perner A; CLASSIC Trial Group. Restriction of Intravenous Fluid in ICU Patients with Septic Shock. N Engl J Med. 2022 Jun 30;386(26):2459-2470. doi: 10.1056/NEJMoa2202707. Epub 2022 Jun 17.
- Background: PubMed 33009098Messmer AS, Zingg C, Muller M, Gerber JL, Schefold JC, Pfortmueller CA. Fluid Overload and Mortality in Adult Critical Care Patients-A Systematic Review and Meta-Analysis of Observational Studies. Crit Care Med. 2020 Dec;48(12):1862-1870. doi: 10.1097/CCM.0000000000004617.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 26507493Marik P, Bellomo R. A rational approach to fluid therapy in sepsis. Br J Anaesth. 2016 Mar;116(3):339-49. doi: 10.1093/bja/aev349. Epub 2015 Oct 27.
- Background: PubMed 30122506Jalil BA, Cavallazzi R. Predicting fluid responsiveness: A review of literature and a guide for the clinician. Am J Emerg Med. 2018 Nov;36(11):2093-2102. doi: 10.1016/j.ajem.2018.08.037. Epub 2018 Aug 14.
- Background: PubMed 3106446Gil Cebrian J, Bello Camara MP, Diaz-Alersi R. APACHE II. Intensive Care Med. 1987;13(2):143. No abstract available.
- Individual participant dataSharing planned: No
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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.
Walid Youssef Kamel, Associate Professor study director
AinShams university
Heba Mohamed El-Serwi, Professor study director
AinShams university
Marwa Mamdoud El-Far, Assistant Professor study director
AinShams university
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Fluid Reponsiveness, run by Ain Shams University.
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 6 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed ElSherbini El-Saedy, bachelor (+010037407868, mmelsherbini365@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral versus lung ultrasound (time frame: 12 hours). The study lists 2 primary outcomes in all. 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 NCT07797751, which also lists 16 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 1 Sep 2026.