SepsisNCT06684340
Risk Factors Identification of Sepsis and Septic Shock After Major Abdominal Surgery Based on Artificial Intelligence
An observational study of Sepsis and Postoperative Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
The goal of this observational study is to identify the risk factors and build the early warning system of sepsis and septic shock after major abdominal surgery based on artificial intelligence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Postoperative Complications
- What is being tested?
- Exposure to major abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 22,646 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Jul 2024
- Phase
- Observational
- 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
Study population: Internal Cohort: Patients who received major abdominal surgery in each participating hospital before June 2024. External Cohort: Patients who received major abdominal surgery, received general anesthesia, and were aged 18 years or older from 2008 to 2019. The data was extracted from the MIMIC - IV (Medical Information Mart for Intensive Care, 2.2 version) database.
Who may be able to join
- Patients undergoing major abdominal surgery.
- The surgeon performing the operation has extensive experience in specialized surgeries such as upper gastrointestinal, hepatobiliary and pancreatic, colorectal, gynecological, and urological surgeries, having completed at least 50 corresponding specialized surgical cases.
- The anesthesiologist performing the operation has more than 5 years of clinical experience.
- All surgical patients receive general anesthesia.
- Patients are aged ≥ 18 years. Exclusion Criteria：
- 1. Pregnancy-related surgeries (cesarean section, abortion surgery). 2. Patients with known preoperative infection or suspected infection. 3. Severely malnourished patients (BMI reference values are 17 kg/m² for patients < 70 years old and 17.8 kg/m² for patients > 70 years old).
- 4. Patients who have previously undergone abdominal surgery. 5. Patients without sufficient data, including demographic variables (such as age, gender), surgical details (surgery duration, surgical grade, anesthesia grade, anesthesia duration), and hospitalization details (such as ICU stay, in-hospital mortality).
Who cannot join
None listed.
About this study
Official title: Construction of AI-enabled Models for Predicting the Risk of Sepsis After Major Abdominal Surgery: a Retrospective Multicenter Clinical Study
The goal of this observational study is to identify the risk factors and build the early warning system of sepsis and septic shock after major abdominal surgery based on artificial intelligence. The main questions it aims to answer are:
What are the high risk factors of postoperative sepsis? Which factors can accelerate the progression of sepsis? Researchers will collect perioperative characteristics to construct predictive models of postoperative sepsis in a retrospective abdominal surgical population based on artificial intelligence, and the accuracy of the models were tested in an external dataset.
- Conditions
- Sepsis, Postoperative Complications
- Being tested
- Exposure to major abdominal surgery
- Medical subject headings
- Sepsis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to major abdominal surgeryProcedure or surgery
This study is a retrospective cohort study. The 'exposure' situation is based on historical records and observation, and no active intervention has been conducted on the study subjects to change their exposure status.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis within 28 days after surgery.
For patients within 28 days after surgery, if there is a recorded or suspected infection and the Sequential Organ Failure Assessment (SOFA) score is ≥ 2 points, sepsis can be diagnosed. For sepsis patients, if they still have persistent hypotension after adequate volume resuscitation and require vasopressor drugs to maintain a Mean Atrial Pressure (MAP) ≥ 65 mmHg and a serum lactate level > 2 mmol/L, it is considered that the sepsis patient has progressed to septic shock.
Measured: In the 28-day period following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2014
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22,646 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684340
- Sponsor's protocol ID
- XH-24-009
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of AI-enabled Models for Predicting the Risk of Sepsis After Major Abdominal Surgery: a Retrospective Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06684340
- Acronym / sponsor ID
- XH-24-009
- Conditions
- Sepsis, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,646 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 12 Nov 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.
The goal of this observational study is to identify the risk factors and build the early warning system of sepsis and septic shock after major abdominal surgery based on artificial intelligence. The main questions it aims to answer are:
What are the high risk factors of postoperative sepsis? Which factors can accelerate the progression of sepsis? Researchers will collect perioperative characteristics to construct predictive models of postoperative sepsis in a retrospective abdominal surgical population based on artificial intelligence, and the accuracy of the models were tested in an external dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Internal Cohort: Patients who received major abdominal surgery in each participating hospital before June 2024. External Cohort: Patients who received major abdominal surgery, received general anesthesia, and were aged 18 years or older from 2008 to 2019. The data was extracted from the MIMIC - IV (Medical Information Mart for Intensive Care, 2.2 version) database.
Key inclusion criteria (7 listed)
- Patients undergoing major abdominal surgery.
- The surgeon performing the operation has extensive experience in specialized surgeries such as upper gastrointestinal, hepatobiliary and pancreatic, colorectal, gynecological, and urological surgeries, having completed at least 50 corresponding specialized surgical cases.
- The anesthesiologist performing the operation has more than 5 years of clinical experience.
- All surgical patients receive general anesthesia.
- Patients are aged ≥ 18 years. Exclusion Criteria：
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Exposure to major abdominal surgeryThis study is a retrospective cohort study. The 'exposure' situation is based on historical records and observation, and no active intervention has been conducted on the study subjects to change their exposure status. | Procedure or surgery | – |
Primary outcome
Sepsis within 28 days after surgery.
Time frame: In the 28-day period following surgery
For patients within 28 days after surgery, if there is a recorded or suspected infection and the Sequential Organ Failure Assessment (SOFA) score is ≥ 2 points, sepsis can be diagnosed. For sepsis patients, if they still have persistent hypotension after adequate volume resuscitation and require vasopressor drugs to maintain a Mean Atrial Pressure (MAP) ≥ 65 mmHg and a serum lactate level > 2 mmol/L, it is considered that the sepsis patient has progressed to septic shock.
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Postoperative Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 7 inclusion and 0 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Sepsis within 28 days after surgery. (time frame: In the 28-day period following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.