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| Name | Class |
|---|---|
| Ningbo No. 1 Hospital | OTHER |
| Lishui Country People's Hospital | OTHER |
| The Central Hospital of Lishui City | OTHER |
| Zhejiang Provincial Tongde Hospital |
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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.
Sepsis, defined as life-threatening organ dysfunction, is caused by a dysregulated host response to infection, which 30-day mortality rate is about 24.4%. Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dobutamine, norepinephrine | Experimental | 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 |
|
| Norepinephrine | Other | Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dobutamine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney injury after surgery | Incidence of acute kidney injury after surgery | within 1 week after surgery |
| Sequential Organ Failure Assessment (SOFA) score | Sequential Organ Failure Assessment (SOFA) score, ranges from 0 to 24, with 24 being the worst | Day 1 Day 3 and Day 7 in ICU after surgery |
| Mortality | Mortality | in hospital and Day 28 and Day 90 after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate level measurement | Lactate level measurement | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey |
| capillary filling time | capillary filling time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34599691 | 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. | |
| 26903338 |
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Study protocol
after finishing the study
The protocol is available from the investigator on reasonable request.
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| ID | Term |
|---|---|
| D004280 | Dobutamine |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
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Not provided
| 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 Municipal Hospital | OTHER |
| 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 Affilated Hospital of the Medical College, Shihezi University | OTHER |
| 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 |
| Zhejiang Provincial People's Hospital | OTHER |
| 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 |
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| Norepinephrine | Drug | Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups. |
|
| before surgery (0 hour), 1hour after begining of surgery and at the end of surgey |
| Central venous oxygen saturation (ScvO2) | Central venous oxygen saturation (ScvO2) | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey |
| Urine volume | Urine volume | 1hour after begining of surgery and at the end of surgey |
| Duration of norepinephrine intraoperatively | Duration of norepinephrine intraoperatively | intraoperatively |
| Cumulative dose of norepinephrine intraoperatively | Cumulative dose of norepinephrine intraoperatively | intraoperatively |
| Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia | Incidence of intraoperative arrythmia | intraoperatively |
| Postoperative complication | Postoperative complication | through study completion, an average of 1 year |
| Length of hospital stay after sugery | Length of hospital stay after sugery | through study completion, an average of 1 year |
| ICU-free days with 28 days postoperatively | ICU-free days with 28 days postoperatively | 28 days postoperatively |
| Duration of mechanical ventilation in ICU | Duration of mechanical ventilation in ICU | through study completion, an average of 1 year |
| Renal replacement therapy | Renal replacement therapy within the first 7 days after the surgery | through study completion, an average of 1 year |
| Duration of renal replacement therapy | Duration of renal replacement therapy | through study completion, an average of 1 year |
| ICU-Mortality | ICU-Mortality | through study completion, an average of 1 year |
| In-hosipital Mortality | In-hosipital Mortality | through study completion, an average of 1 year |
| Hospitalization costs | Hospitalization costs | through study completion, an average of 1 year |
| 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. |
| 32430052 | 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. |
| 21975865 | 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. |
| 32736541 | 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. |
| 16106006 | 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. |
| 23622885 | 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. |
| 25500400 | 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. |
| 17452940 | 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. |
| 34758739 | 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. |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |