drugset / Trial / NCT06462313
Dobutamine for Management of Surgical Patients With Septic Shock
Completed
584 enrolled
First Affiliated Hospital of Zhejiang University
Affiliated Hospital of Guangdong Medical University · collabAffiliated Hospital of Jiaxing University · collabAnqing Municipal Hospital · collabCentral Hospital of Heng Yang · collabFirst Affiliated Hospital of Shenzhen University · collabFirst Affiliated Hospital of Xinjiang Medical University · collabFujian Provincial Hospital · collabFuyang Hospital of Anhui Medical University · collabGuizhou Provincial People's Hospital · collabHenan Provincial People's Hospital · collabHuaibei Peolple's Hospital · collabLishui Country People's Hospital · collabNingbo No. 1 Hospital · collabNingbo No.2 Hospital · collabPeople's Hospital of Xinjiang Uygur Autonomous Region · collabRed Cross Hospital, Hangzhou, China · collabRenmin Hospital of Wuhan University · collabSouthwest Hospital, China · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe Central Hospital of Lishui City · collabThe First Affilated Hospital of the Medical College, Shihezi University · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Soochow University · collabThe First Affiliated Hospital of University of South China · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Clinical College of Harbin University · collabThe First People's Hospital of Zunyi · collabThe Hospital of Suixi County · collabThe Second Hospital University of South China · collabThe Second Hospital of Hebei Medical University · collabTianjin Medical University General Hospital · collabTongji Hospital · collabUnion hospital of Fujian Medical University · collabWeifang People's Hospital · collabWeihai Municipal Hospital · collabWenzhou people's hospital,zhejiang province,China · collabWuhan Third Hospital · collabZhejiang Cancer Hospital · collabZhejiang Provincial People's Hospital · collabZhejiang Provincial Tongde Hospital · collabZhujiang Hospital · collabZunyi Medical College · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.
Timeline
- Start
- 2024-06-18
- Primary completion
- 2025-11-15
- Completion
- 2025-11-15
Publications
- Background 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.
- Background Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background Bauer M, Gerlach H, Vogelmann T, Preissing F, Stiefel J, Adam D. Mortality in sepsis and septic shock in Europe, North America and Australia between 2009 and 2019- results from a systematic review and meta-analysis. Crit Care. 2020 May 19;24(1):239. doi: 10.1186/s13054-020-02950-2.
- Background Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
- Background Liu J, Xie H, Ye Z, Li F, Wang L. Rates, predictors, and mortality of sepsis-associated acute kidney injury: a systematic review and meta-analysis. BMC Nephrol. 2020 Jul 31;21(1):318. doi: 10.1186/s12882-020-01974-8.
- Background Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
- Background Yang HS, Song BG, Kim JY, Kim SN, Kim TY. Impact of propofol anesthesia induction on cardiac function in low-risk patients as measured by intraoperative Doppler tissue imaging. J Am Soc Echocardiogr. 2013 Jul;26(7):727-35. doi: 10.1016/j.echo.2013.03.016. Epub 2013 Apr 24.
- Background Green DW. Cardiac output decrease and propofol: what is the mechanism? Br J Anaesth. 2015 Jan;114(1):163-4. doi: 10.1093/bja/aeu424. No abstract available.
- Background Rudiger A, Singer M. Mechanisms of sepsis-induced cardiac dysfunction. Crit Care Med. 2007 Jun;35(6):1599-608. doi: 10.1097/01.CCM.0000266683.64081.02.
- Background Zhu Y, Yin H, Zhang R, Ye X, Wei J. The effect of dobutamine in sepsis: a propensity score matched analysis. BMC Infect Dis. 2021 Nov 11;21(1):1151. doi: 10.1186/s12879-021-06852-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dobutamine | Small molecule | 5 ug/kg | — |
| Background | Norepinephrine | Other / unclassified | — | — |