Dobutamine for Management of Surgical Patients With Septic Shock

NCT06462313 | Completed

• 1 other identifier: Dobutamine
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patients With Septic Shock; Surgical Patients; General Anesthesia

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (16)

• Lactate level measurement

  before surgery (0 hour), 1hour after begining of surgery and at the end of surgey

• capillary filling time

  before surgery (0 hour), 1hour after begining of surgery and at the end of surgey

• Central venous oxygen saturation (ScvO2)

  before surgery (0 hour), 1hour after begining of surgery and at the end of surgey

• Urine volume

  1hour after begining of surgery and at the end of surgey

• Duration of norepinephrine intraoperatively

  intraoperatively

Study Arms (2)

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

Drug: Dobutamine; Drug: Norepinephrine

Norepinephrine

OTHER

Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more

Drug: Norepinephrine

Interventions

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.

Dobutamine, norepinephrine

Norepinephrine DRUG

Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.

Dobutamine, norepinephrine; Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 18 years or older
• Sugery patients with septic shock and the duration of opration is more than 1 hour

You may not qualify if:

• Pregnancy;
• Long-term intakeβ-receptor blocker;
• patietns with dobutamine used within 72h before enrollment;
• Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 72h before enrollment;
• Patients with hyperthyroidism;
• Allergy or known sensitivity to catecholamines（norepinephrine, dobutamine etc.）and genera anesthetics.
• Patients and guardians refused to participate in this intervention clinical trial.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Ningbo No. 1 Hospital: collaborator
• Lishui Country People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Ningbo No.2 Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Zunyi Medical College: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Huaibei Peolple's Hospital: collaborator
• Anqing People's Hospital of Anhui Medical University: collaborator
• The Second Hospital University of South China: collaborator
• The First Affiliated Hospital of University of South China: collaborator
• Wenzhou people's hospital，zhejiang province,China: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• The First Clinical College of Harbin University: collaborator
• The First Affiliated Hospital of Shihezi University Medical College: collaborator
• Weifang People's Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Central Hospital of Heng Yang: collaborator
• First Affiliated Hospital of Shenzhen University: collaborator
• Henan Provincial People's Hospital: collaborator
• Southwest Hospital, China: collaborator
• The First People's Hospital of Zunyi: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Union hospital of Fujian Medical University: collaborator
• Bijie Hospital of Zhejiang Provincial People's Hospital: collaborator
• Red Cross Hospital, Hangzhou, China: collaborator
• Weihai Municipal Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Wuhan Third Hospital: collaborator
• Tongji Hospital: collaborator
• Zhujiang Hospital: collaborator
• Fuyang Hospital of Anhui Medical University: collaborator
• The Hospital of Suixi County: collaborator
• Fujian Provincial Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (10)

• 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.

  PMID: 34599691 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.

  PMID: 26903338 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.

  PMID: 32430052 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.

  PMID: 21975865 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.

  PMID: 32736541 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.

  PMID: 16106006 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.

  PMID: 23622885 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.

  PMID: 25500400 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.

  PMID: 17452940 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.

  PMID: 34758739 BACKGROUND

MeSH Terms

Interventions

Dobutamine; Norepinephrine

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 17, 2024
• Study Start: June 18, 2024
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after finishing the study
• Access Criteria: The protocol is available from the investigator on reasonable request.

Locations

CN (1)