Intensive Care Unit SyndromeNCT06277518
System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
An observational study of Intensive Care Unit Syndrome, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Surgery for malignant tumors of the digestive system
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 20 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery for malignant tumors of digestive system under general anesthesia in Shaanxi Provincial Cancer Hospital and Ningxia Medical University General Hospital from January 2019 to December 2023
Who may be able to join
- Postoperative patients with malignant tumor of digestive system under general anesthesia, ASA Ⅱ~ Ⅳ
Who cannot join
- Emergency operation, operation stopped after entering the operating room, ASA > Ⅳ
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Establishment and Application of Decision System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor.
Read the detailed description
The incidence of malignant tumors of digestive system is increasing year by year in the world, and surgical treatment is the first choice for malignant tumors of digestive system. Most of these patients were elderly, had more complications before surgery, had greater surgical trauma, and had a high proportion of postoperative ICU admission. In recent three years, 28.1% of patients with malignant tumor of digestive system were admitted to ICU after surgery. The study found that postoperative ICU care in critically ill patients was conducive to reducing mortality, while non-essential postoperative ICU care in some patients was associated with the worst outcome. At present, there is still a lack of accurate and reliable decision making system for postoperative admission to ICU for patients with digestive system malignancies at home and abroad. Therefore, this project intends to establish a predictive model for postoperative ICU admission of patients with malignant tumors of the digestive system, develop a friendly interface that is convenient for medical care, help medical care quickly determine the biggest beneficiaries of postoperative ICU admission, rationally allocate medical resources, improve medical quality, reduce medical costs, ensure perioperative safety of patients, and promote postoperative rehabilitation of patients. At present, there is still a lack of accurate and reliable decision making system for postoperative admission to ICU for patients with digestive system malignancies at home and abroad. Therefore, this project intends to establish a predictive model for postoperative ICU admission of patients with malignant tumors of the digestive system, develop a friendly interface that is convenient for medical care, help medical care quickly determine the biggest beneficiaries of postoperative ICU admission, rationally allocate medical resources, improve medical quality, reduce medical costs, ensure perioperative safety of patients, and promote postoperative rehabilitation of patients.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Surgery for malignant tumors of the digestive system
- Keywords
- Malignant tumors of digestive system, Intensive care Unit, risk factors, predictive models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for malignant tumors of the digestive systemProcedure or surgery
Related treatment or palliative surgery under general anesthesia for digestive system malignancies
| Study group | Role | What they receive |
|---|---|---|
| observation group, | the risk factors of patients with malignant tumors of digestive system meeting the inclusion criteria were observed without special intervention Receives: Procedure: Surgery for malignant tumors of the digestive system |
What is being measured
The primary outcome is the main question the study is designed to answer.
admitted to ICU after surgery
whether the patient was admitted to ICU after surgery or within three days
Measured: the day and three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start20 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liqin Deng, M.D, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277518
- Sponsor's protocol ID
- Liqin Deng
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Application of Decision System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
- ClinicalTrials.gov ID
- NCT06277518
- Acronym / sponsor ID
- Liqin Deng
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Malignant tumors of digestive system, Intensive care Unit, risk factors, predictive models
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 26 Feb 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.
Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor.
Detailed description
The incidence of malignant tumors of digestive system is increasing year by year in the world, and surgical treatment is the first choice for malignant tumors of digestive system. Most of these patients were elderly, had more complications before surgery, had greater surgical trauma, and had a high proportion of postoperative ICU admission. In recent three years, 28.1% of patients with malignant tumor of digestive system were admitted to ICU after surgery. The study found that postoperative ICU care in critically ill patients was conducive to reducing mortality, while non-essential postoperative ICU care in some patients was associated with the worst outcome. At present, there is still a lack of accurate and reliable decision making system for postoperative admission to ICU for patients with digestive system malignancies at home and abroad. Therefore, this project intends to establish a predictive model for postoperative ICU admission of patients with malignant tumors of the digestive system, develop a friendly interface that is convenient for medical care, help medical care quickly determine the biggest beneficiaries of postoperative ICU admission, rationally allocate medical resources, improve medical quality, reduce medical costs, ensure perioperative safety of patients, and promote postoperative rehabilitation of patients. At present, there is still a lack of accurate and reliable decision making system for postoperative admission to ICU for patients with digestive system malignancies at home and abroad. Therefore, this project intends to establish a predictive model for postoperative ICU admission of patients with malignant tumors of the digestive system, develop a friendly interface that is convenient for medical care, help medical care quickly determine the biggest beneficiaries of postoperative ICU admission, rationally allocate medical resources, improve medical quality, reduce medical costs, ensure perioperative safety of patients, and promote postoperative rehabilitation of patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group, | – | Procedure: Surgery for malignant tumors of the digestive systemthe risk factors of patients with malignant tumors of digestive system meeting the inclusion criteria were observed without special intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery for malignant tumors of digestive system under general anesthesia in Shaanxi Provincial Cancer Hospital and Ningxia Medical University General Hospital from January 2019 to December 2023
Key inclusion criteria (1 listed)
- Postoperative patients with malignant tumor of digestive system under general anesthesia, ASA Ⅱ~ Ⅳ
Key exclusion criteria (1 listed)
- Emergency operation, operation stopped after entering the operating room, ASA > Ⅳ
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 |
|---|---|---|
| Surgery for malignant tumors of the digestive systemRelated treatment or palliative surgery under general anesthesia for digestive system malignancies | Procedure or surgery | observation group, |
Primary outcome
admitted to ICU after surgery
Time frame: the day and three days after surgery
whether the patient was admitted to ICU after surgery or within three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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.
Liqin Deng, M.D principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by General Hospital of Ningxia Medical 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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?
Results are not available in the source record.
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?
admitted to ICU after surgery (time frame: the day and three days after 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 26 Feb 2024.