Dobutamine for Management of Surgical Patients With Septic Shock
NCT ID: NCT06462313
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
584 participants
INTERVENTIONAL
2024-06-18
2025-11-15
Brief Summary
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Detailed Description
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Surgical patients with septic shock are not rare. 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, furthermore exacerbate hemodynamic instability, and then increase the incidence of AKI and patient mortality. Therefore, to improve cardiac function in patients with septic shock who received general anesthesia is the key to save patients life and improve prognosis.
The latest international guidelines for the treatment of septic shock recommend - in patients with septic shock combined with cardiac dysfunction, treatment with norepinephrine in combination with dobutamine is recommended if inadequate tissue perfusion persists after adequate fluid resuscitation and maintenance of blood pressure, but the level of evidence is weak.
Dobutamine acts on β-adrenergic receptors, which can improve tissue perfusion, and small doses of 2.5-5ug/kg/min can increase myocardial contractility and improve cardiac function in patients without increasing heart rate. Previous study has demonstrated that the combined use of norepinephrine and dobutamine can elevate left ventricular ejection fraction, cardiac index, improve tissue perfusion, and reduce mortality in patients with septic shock. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dobutamine, norepinephrine
Patients will be initiated on Dobutamine at 5 mcg/kg/min while continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 65mmHg or more
Dobutamine
Patients with septic shock in Dobutamine group will be initiated on Dobutamine at 5 mcg/kg/min when electrocardiogram, invasive blood pressure, and oxygen saturation were monitored.
Norepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
Norepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more
Norepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
Interventions
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Dobutamine
Patients with septic shock in Dobutamine group will be initiated on Dobutamine at 5 mcg/kg/min when electrocardiogram, invasive blood pressure, and oxygen saturation were monitored.
Norepinephrine
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
Eligibility Criteria
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Inclusion Criteria
2. Sugery patients with septic shock and the duration of opration is more than 1 hour
Exclusion Criteria
2. Long-term intakeβ-receptor blocker;
3. patietns with dobutamine used within 72h before enrollment;
4. Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 72h before enrollment;
5. Patients with hyperthyroidism;
6. Allergy or known sensitivity to catecholamines（norepinephrine, dobutamine etc.）and genera anesthetics.
7. Patients and guardians refused to participate in this intervention clinical trial.
18 Years
ALL
No
Sponsors
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Ningbo No. 1 Hospital
OTHER
Lishui Country People's Hospital
OTHER
The Central Hospital of Lishui City
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Ningbo No.2 Hospital
OTHER
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Zunyi Medical College
OTHER
The Second Hospital of Hebei Medical University
OTHER
Affiliated Hospital of Jiaxing University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Huaibei Peolple's Hospital
UNKNOWN
Anqing People's Hospital of Anhui Medical University
UNKNOWN
The Second Hospital University of South China
OTHER
The First Affiliated Hospital of University of South China
OTHER
Wenzhou people's hospital，zhejiang province,China
UNKNOWN
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
The First Clinical College of Harbin University
UNKNOWN
The First Affiliated Hospital of Shihezi University Medical College
UNKNOWN
Weifang People's Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Central Hospital of Heng Yang
UNKNOWN
First Affiliated Hospital of Shenzhen University
UNKNOWN
Henan Provincial People's Hospital
OTHER
Southwest Hospital, China
OTHER
The First People's Hospital of Zunyi
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
Union hospital of Fujian Medical University
OTHER
Bijie Hospital of Zhejiang Provincial People's Hospital
UNKNOWN
Red Cross Hospital, Hangzhou, China
OTHER
Weihai Municipal Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Zhejiang Cancer Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
Wuhan Third Hospital
OTHER
Tongji Hospital
OTHER
Zhujiang Hospital
OTHER
Fuyang Hospital of Anhui Medical University
UNKNOWN
The Hospital of Suixi County
UNKNOWN
Fujian Provincial Hospital
OTHER
Guizhou Provincial People's Hospital
OTHER
Zhejiang Provincial People's Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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xiangming fang
professor
Locations
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The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Dobutamine
Identifier Type: -
Identifier Source: org_study_id
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