- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mohamed ElSherbini El-Saedy, bachelor
- Numéro de téléphone: +010037407868
- E-mail: mmelsherbini365@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral versus lung ultrasound
Délai: 12 hours
|
12 hours
|
|
Early detection of fluid accumulation syndrome in septic shock patients using velocity time integral ursus lung ultrasound.
Délai: 12 hours
|
12 hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Walid Youssef Kamel, Associate Professor, AinShams university
- Directeur d'études: Heba Mohamed El-Serwi, Professor, AinShams university
- Directeur d'études: Marwa Mamdoud El-Far, Assistant Professor, AinShams university
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MS932/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .