Patients With Septic ShockNCT06462313
Dobutamine for Management of Surgical Patients With Septic Shock
A study testing Dobutamine and Norepinephrine in people with Patients With Septic Shock and Surgical Patients, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Septic Shock, Surgical Patients, General Anesthesia
- What is being tested?
- Dobutamine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 18 years or older
- Sugery patients with septic shock and the duration of opration is more than 1 hour
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
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.
Read the detailed 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.
- Being tested
- Dobutamine, Norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
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.
NorepinephrineDrug
Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dobutamine; Drug: Norepinephrine |
| Norepinephrine | Other | Norepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury after surgery
Incidence of acute kidney injury after surgery
Measured: 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
Measured: Day 1 Day 3 and Day 7 in ICU after surgery
Mortality
Mortality
Measured: in hospital and Day 28 and Day 90 after the surgery
Secondary outcomes (16)
Lactate level measurement
Lactate level measurement
Measured: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
capillary filling time
capillary filling time
Measured: 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)
Measured: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
Urine volume
Urine volume
Measured: 1hour after begining of surgery and at the end of surgey
Duration of norepinephrine intraoperatively
Duration of norepinephrine intraoperatively
Measured: intraoperatively
Cumulative dose of norepinephrine intraoperatively
Cumulative dose of norepinephrine intraoperatively
Measured: intraoperatively
Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia
Incidence of intraoperative arrythmia
Measured: intraoperatively
Postoperative complication
Postoperative complication
Measured: through study completion, an average of 1 year
Length of hospital stay after sugery
Length of hospital stay after sugery
Measured: through study completion, an average of 1 year
ICU-free days with 28 days postoperatively
ICU-free days with 28 days postoperatively
Measured: 28 days postoperatively
Duration of mechanical ventilation in ICU
Duration of mechanical ventilation in ICU
Measured: through study completion, an average of 1 year
Renal replacement therapy
Renal replacement therapy within the first 7 days after the surgery
Measured: through study completion, an average of 1 year
Duration of renal replacement therapy
Duration of renal replacement therapy
Measured: through study completion, an average of 1 year
ICU-Mortality
ICU-Mortality
Measured: through study completion, an average of 1 year
In-hosipital Mortality
In-hosipital Mortality
Measured: through study completion, an average of 1 year
Hospitalization costs
Hospitalization costs
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start18 Jun 2024
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Patients With Septic ShockStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No. 1 Hospital, Lishui Country People's Hospital, The Central Hospital of Lishui City, Zhejiang Provincial Tongde Hospital, Ningbo No.2 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, Zunyi Medical College, The Second Hospital of Hebei Medical University, Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Anhui Medical University, Huaibei Peolple's Hospital, Anqing Municipal Hospital, The Second Hospital University of South China, The First Affiliated Hospital of University of South China, Wenzhou people's hospital，zhejiang province,China, People's Hospital of Xinjiang Uygur Autonomous Region, The First Clinical College of Harbin University, The First Affiliated Hospital of Shihezi University, Weifang People's Hospital, Tianjin Medical University General Hospital, Central Hospital of Heng Yang, First Affiliated Hospital of Shenzhen University, Henan Provincial People's Hospital, Southwest Hospital, China, The First People's Hospital of Zunyi, Affiliated Hospital of Guangdong Medical University, Union hospital of Fujian Medical University, Zhejiang Provincial People's Hospital, Red Cross Hospital, Hangzhou, China, Weihai Municipal Hospital, The First Affiliated Hospital of Soochow University, Zhejiang Cancer Hospital, Renmin Hospital of Wuhan University, Wuhan Third Hospital, Tongji Hospital, Zhujiang Hospital, Fuyang Hospital of Anhui Medical University, The Hospital of Suixi County, Fujian Provincial Hospital, Guizhou Provincial People's Hospital
- Responsible party
- Principal investigator, xiangming fang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462313
- Sponsor's protocol ID
- Dobutamine
- Status last verified
- Nov 2025
- First submitted
- 23 May 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Publications
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.
PubMed 34599691Singer 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.
PubMed 26903338Bauer 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.
PubMed 32430052Singbartl 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.
PubMed 21975865Liu 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.
PubMed 32736541Uchino 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.
PubMed 16106006Yang 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.
PubMed 23622885Green 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.
PubMed 25500400Rudiger 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.
PubMed 17452940Zhu 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.
PubMed 34758739Chinese Perioperative Septic Shock Investigators for the Chinese Peri-Operative Organ Protection Group; Chu L, Xie G, Shi R, Ye H, Wu S, Hua Y, Wang B, Tang M, Xu Z, Wang Q, Cui P, Ye J, Hong Y, Wang J, Xu G, Li Q, Wang C, Zheng F, Xia Z, Song W, Wang M, Chen L, Lu X, Liu X, Zheng Q, Tang J, Yan Z, Lang B, Yan Q, Liu W, Luo J, Wang K, Lu Y, Huang C, Wang J, Zhang H, Li F, Lu K, Yi B, Gu J, Wu J, Duan G, Li C, Luo F, Wang H, Zhang J, Han Y, Tan D, Wen J, Wan H, Hu G, Yu T, Wang H, Mei W, Liu Z, Yu S, Guan Y, Wang X, Ma B, Yang Y, Wang H, Wu X, Chen Y, Lai Z, Han X, Ji F, Yang S, Wu Y, Li R, Xu P, Yang J, Nian C, Yu Y, Wang H, An X, Cheng B, Li H, Song S, Ma D, Islam N, Fang X. Intraoperative Dobutamine Plus Norepinephrine to Prevent Postoperative Acute Kidney Injury in Septic Shock: A Randomized Clinical Trial. JAMA. 2026 Oct 14. doi: 10.1001/jama.2026.21322. Online ahead of print.
PubMed 42872914
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
- ClinicalTrials.gov ID
- NCT06462313
- Acronym / sponsor ID
- Dobutamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ningbo No. 1 Hospital, Lishui Country People's Hospital, The Central Hospital of Lishui City, Zhejiang Provincial Tongde Hospital, Ningbo No.2 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, Zunyi Medical College, The Second Hospital of Hebei Medical University, Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Anhui Medical University, Huaibei Peolple's Hospital, Anqing Municipal Hospital, The Second Hospital University of South China, The First Affiliated Hospital of University of South China, Wenzhou people's hospital，zhejiang province,China, People's Hospital of Xinjiang Uygur Autonomous Region, The First Clinical College of Harbin University, The First Affiliated Hospital of Shihezi University, Weifang People's Hospital, Tianjin Medical University General Hospital, Central Hospital of Heng Yang, First Affiliated Hospital of Shenzhen University, Henan Provincial People's Hospital, Southwest Hospital, China, The First People's Hospital of Zunyi, Affiliated Hospital of Guangdong Medical University, Union hospital of Fujian Medical University, Zhejiang Provincial People's Hospital, Red Cross Hospital, Hangzhou, China, Weihai Municipal Hospital, The First Affiliated Hospital of Soochow University, Zhejiang Cancer Hospital, Renmin Hospital of Wuhan University, Wuhan Third Hospital, Tongji Hospital, Zhujiang Hospital, Fuyang Hospital of Anhui Medical University, The Hospital of Suixi County, Fujian Provincial Hospital, Guizhou Provincial People's Hospital
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dobutamine, norepinephrine | Experimental | Drug: Dobutamine, Drug: NorepinephrinePatients 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 | Drug: NorepinephrineNorepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with 18 years or older
- Sugery patients with septic shock and the duration of opration is more than 1 hour
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DobutaminePatients 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. | Drug | Dobutamine, norepinephrine |
| NorepinephrineNorepinephrine was titrated to maintain a mean arterial pressure at 65mmHg or more in both groups. | Drug | Dobutamine, norepinephrine, Norepinephrine |
Primary outcome
Incidence of acute kidney injury after surgery
Time frame: within 1 week after surgery
Incidence of acute kidney injury after surgery
Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 1 Day 3 and Day 7 in ICU after surgery
Sequential Organ Failure Assessment (SOFA) score, ranges from 0 to 24, with 24 being the worst
Mortality
Time frame: in hospital and Day 28 and Day 90 after the surgery
Mortality
16 secondary outcomes
Lactate level measurement
Time frame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
capillary filling time
Time frame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
Central venous oxygen saturation (ScvO2)
Time frame: before surgery (0 hour), 1hour after begining of surgery and at the end of surgey
Urine volume
Time frame: 1hour after begining of surgery and at the end of surgey
Duration of norepinephrine intraoperatively
Time frame: intraoperatively
Cumulative dose of norepinephrine intraoperatively
Time frame: intraoperatively
Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia
Time frame: intraoperatively
Postoperative complication
Time frame: through study completion, an average of 1 year
Length of hospital stay after sugery
Time frame: through study completion, an average of 1 year
ICU-free days with 28 days postoperatively
Time frame: 28 days postoperatively
Duration of mechanical ventilation in ICU
Time frame: through study completion, an average of 1 year
Renal replacement therapy
Time frame: through study completion, an average of 1 year
Duration of renal replacement therapy
Time frame: through study completion, an average of 1 year
ICU-Mortality
Time frame: through study completion, an average of 1 year
In-hosipital Mortality
Time frame: through study completion, an average of 1 year
Hospitalization costs
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 34599691Evans 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 32430052Bauer 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.
- Background: PubMed 21975865Singbartl 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.
- Background: PubMed 32736541Liu 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.
- Background: PubMed 16106006Uchino 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.
- Background: PubMed 23622885Yang 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.
- Background: PubMed 25500400Green 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.
- Background: PubMed 17452940Rudiger 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.
- Background: PubMed 34758739Zhu 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.
- Derived from this study: PubMed 42872914Chinese Perioperative Septic Shock Investigators for the Chinese Peri-Operative Organ Protection Group; Chu L, Xie G, Shi R, Ye H, Wu S, Hua Y, Wang B, Tang M, Xu Z, Wang Q, Cui P, Ye J, Hong Y, Wang J, Xu G, Li Q, Wang C, Zheng F, Xia Z, Song W, Wang M, Chen L, Lu X, Liu X, Zheng Q, Tang J, Yan Z, Lang B, Yan Q, Liu W, Luo J, Wang K, Lu Y, Huang C, Wang J, Zhang H, Li F, Lu K, Yi B, Gu J, Wu J, Duan G, Li C, Luo F, Wang H, Zhang J, Han Y, Tan D, Wen J, Wan H, Hu G, Yu T, Wang H, Mei W, Liu Z, Yu S, Guan Y, Wang X, Ma B, Yang Y, Wang H, Wu X, Chen Y, Lai Z, Han X, Ji F, Yang S, Wu Y, Li R, Xu P, Yang J, Nian C, Yu Y, Wang H, An X, Cheng B, Li H, Song S, Ma D, Islam N, Fang X. Intraoperative Dobutamine Plus Norepinephrine to Prevent Postoperative Acute Kidney Injury in Septic Shock: A Randomized Clinical Trial. JAMA. 2026 Oct 14. doi: 10.1001/jama.2026.21322. Online ahead of print.
- Individual participant dataSharing planned: Yes. Study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dobutamine and Norepinephrine in people with Patients With Septic Shock and Surgical Patients, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury after surgery (time frame: within 1 week after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462313, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.