Dobutamine for Management of Surgical Patients With Septic Shock

General Anesthesia Clinical Trial

Official title:

Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462313
• Other study ID #: Dobutamine
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: June 2024
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• General Anesthesia
• Patients With Septic Shock
• Shock, Septic
• Surgical Patients

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
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

References & Publications (10)

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

Outcome

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