- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07797751
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 (lvotvti)
Comparing Lung Ultrasonography and Left Ventricular Outflow Tract Velocity Time Integral for Early Detection of Fluid Overload After Fluid Resuscitation in Septic Shock Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed ElSherbini El-Saedy, bachelor
- Phone Number: +010037407868
- Email: mmelsherbini365@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged ≥ 18 years with septic shock.
- Mean arterial pressure (MAP) <65 mmHg.
- Need fluid resuscitation.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral versus lung ultrasound
Time Frame: 12 hours
|
12 hours
|
|
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral ursus lung ultrasound.
Time Frame: 12 hours
|
12 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Walid Youssef Kamel, Associate Professor, AinShams university
- Study Director: Heba Mohamed El-Serwi, Professor, AinShams university
- Study Director: Marwa Mamdoud El-Far, Assistant Professor, AinShams university
Publications and helpful links
General Publications
- Rhodes 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.
- Evans 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.
- Enghard 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.
- Marik 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.
- Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care. 2015 Jun 15;19(1):251. doi: 10.1186/s13054-015-0970-1.
- Messmer 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.
- Meyhoff 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.
- McDonagh 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.
- 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.
- Wang 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.
- Spathoulas 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.
- Qayyum S, Shahid K. Fluid Resuscitation in Septic Patients. Cureus. 2023 Aug 29;15(8):e44317. doi: 10.7759/cureus.44317. eCollection 2023 Aug.
- Pfortmueller 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.
- Jalil 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.
- Gil Cebrian J, Bello Camara MP, Diaz-Alersi R. APACHE II. Intensive Care Med. 1987;13(2):143. No abstract available.
- Beshara 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS932/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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