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Completed

NCT Number: NCT06462313

Dobutamine for Management of Surgical Patients With Septic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

norepinephrine

Drug

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

Primary outcomes

  1. Incidence of acute kidney injury after surgery

    Time frame: within 1 week after surgery

    Incidence of acute kidney injury after surgery

  2. 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

  3. Mortality

    Time frame: in hospital and Day 28 and Day 90 after the surgery

    Mortality

Secondary outcomes

  1. Lactate level measurement

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

    Lactate level measurement

  2. capillary filling time

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

    capillary filling time

  3. Central venous oxygen saturation (ScvO2)

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

    Central venous oxygen saturation (ScvO2)

  4. Urine volume

    Time frame: 1hour after begining of surgery and at the end of surgey

    Urine volume

  5. Duration of norepinephrine intraoperatively

    Time frame: intraoperatively

    Duration of norepinephrine intraoperatively

  6. Cumulative dose of norepinephrine intraoperatively

    Time frame: intraoperatively

    Cumulative dose of norepinephrine intraoperatively

  7. Incidence of intraoperative arrythmia Incidence of intraoperative arrythmia

    Time frame: intraoperatively

    Incidence of intraoperative arrythmia

  8. Postoperative complication

    Time frame: through study completion, an average of 1 year

    Postoperative complication

  9. Length of hospital stay after sugery

    Time frame: through study completion, an average of 1 year

    Length of hospital stay after sugery

  10. ICU-free days with 28 days postoperatively

    Time frame: 28 days postoperatively

    ICU-free days with 28 days postoperatively

  11. Duration of mechanical ventilation in ICU

    Time frame: through study completion, an average of 1 year

    Duration of mechanical ventilation in ICU

  12. Renal replacement therapy

    Time frame: through study completion, an average of 1 year

    Renal replacement therapy within the first 7 days after the surgery

  13. Duration of renal replacement therapy

    Time frame: through study completion, an average of 1 year

    Duration of renal replacement therapy

  14. ICU-Mortality

    Time frame: through study completion, an average of 1 year

    ICU-Mortality

  15. In-hosipital Mortality

    Time frame: through study completion, an average of 1 year

    In-hosipital Mortality

  16. Hospitalization costs

    Time frame: through study completion, an average of 1 year

    Hospitalization costs

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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