General Anesthesia Clinical Trial
Official title:
Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
Verified date | June 2024 |
Source | First Affiliated Hospital of Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 584 |
Est. completion date | April 30, 2027 |
Est. primary completion date | April 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with 18 years or older 2. Sugery patients with septic shock and the duration of opration is more than 1 hour Exclusion Criteria: 1. Pregnancy; 2. Patients with a history of Cardiac insufficiency; 3. Patients with acute coronary syndrome within the last 3 months; 4. Patients with severe valvular heart disease; 5. Patients with chronic renal insufficiency; 6. Long-term intakeß-receptor blocker; 7. Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 24 hour before the sugery; 8. Patients with hyperthyroidism; 9. Allergy or known sensitivity to catecholamines(norepinephrine, dobutamine etc.)and genera anesthetics. 10. Patients and guardians refused to participate in this intervention clinical trial. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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First Affiliated Hospital of Zhejiang University | Jining First People's Hospital, Lishui Country People's Hospital, Ningbo No. 1 Hospital, Shenzhen Second People's Hospital, The Central Hospital of Lishui City, The Second Hospital of Hebei Medical University, Weifang People's Hospital, Zhejiang Provincial People's Hospital, Zhejiang Provincial Tongde Hospital, Zunyi Medical College |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of acute kidney injury after surgery | Incidence of acute kidney injury after surgery | 1 week after surgery | |
Primary | 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 | |
Primary | Mortality | Mortality | Day 28 and Day 90 after the surgery | |
Secondary | Lactate level measurement | Lactate level measurement | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey | |
Secondary | capillary filling time | capillary filling time | before surgery (0 hour), 1hour after begining of surgery and at the end of surgey | |
Secondary | 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 | |
Secondary | Urine volume | Urine volume | 1hour after begining of surgery and at the end of surgey | |
Secondary | Duration of norepinephrine intraoperatively | Duration of norepinephrine intraoperatively | intraoperatively | |
Secondary | Cumulative dose of norepinephrine intraoperatively | Cumulative dose of norepinephrine intraoperatively | intraoperatively | |
Secondary | Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia | Incidence of intraoperative arrythmia | intraoperatively | |
Secondary | Postoperative complication | Postoperative complication | through study completion, an average of 1 year | |
Secondary | Length of hospital stay after sugery | Length of hospital stay after sugery | through study completion, an average of 1 year | |
Secondary | ICU-free days with 28 days postoperatively | ICU-free days with 28 days postoperatively | 28 days postoperatively | |
Secondary | Duration of mechanical ventilation in ICU | Duration of mechanical ventilation in ICU | through study completion, an average of 1 year | |
Secondary | Renal replacement therapy | Renal replacement therapy within the first 7 days after the surgery | through study completion, an average of 1 year | |
Secondary | Duration of renal replacement therapy | Duration of renal replacement therapy | through study completion, an average of 1 year | |
Secondary | ICU-Mortality | ICU-Mortality | through study completion, an average of 1 year | |
Secondary | In-hosipital Mortality | In-hosipital Mortality | through study completion, an average of 1 year | |
Secondary | Hospitalization costs | Hospitalization costs | through study completion, an average of 1 year |
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