SepsisNCT06634732
Quantitative Ultrasound Assessment of Abdominal Cavity Space
An observational study of Sepsis and MODS, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a prospective observational study to observe the diagnostic efficacy of a quantitative ultrasound assessment plan for pathological accumulation in the abdominal cavity space of critically ill patients, and to explore its correlation with patient clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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: Critically ill patients in the Department of Critical Care Medicine at Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Who may be able to join
- Age \> 18 years old;
- Expected ICU stay ≥ 72 hours;
- Meeting one of the diagnostic criteria for intra-abdominal infection: 1) Single organ infection (such as cholecystitis, appendicitis, diverticulitis, cholangitis, pancreatitis, salpingitis, etc.), which may be accompanied by or without peritonitis, even without perforation; 2) Peritonitis, classified as primary, secondary, or recurrent; 3) Intra-abdominal abscess.
Who cannot join
- Patients with wounds, redness, swelling, bleeding, or other conditions at the abdominal measurement points that prevent ultrasound assessment;
- Patients with intra-abdominal gas accumulation that affects abdominal ultrasound imaging, making ultrasound quantitative scoring impossible;
- Patients who have not undergone abdominal CT examination within 72 hours of ICU admission;
- Patients who do not consent to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Study on the Application Value of Quantitative Ultrasound Assessment Plan for Abdominal Cavity Space in Critically Ill Patients
This is a prospective observational study to observe the diagnostic efficacy of a quantitative ultrasound assessment plan for pathological accumulation in the abdominal cavity space of critically ill patients, and to explore its correlation with patient clinical outcomes.
Read the detailed description
Intra-abdominal lesions, such as hemorrhage and inflammation/infection, often lead to pathological accumulations, posing serious challenges for critically ill patients. These lesions can rapidly induce intra-abdominal hypertension and organ damage, which may progress to hemorrhagic or septic shock, endangering patients\' lives. Intra-abdominal hemorrhage, especially surgery-related hemorrhage, is difficult to detect early, and existing assessment methods like CT scans have limited applicability in critically ill patients. Intra-abdominal infections account for a high proportion of infections in critically ill patients, with concurrent sepsis or shock having high mortality rates. Despite advancements in critical care medicine, the mortality rate from intra-abdominal infections remains stubbornly high. Accurate assessment of the source and extent of infection is crucial for treatment, yet routine physical examinations have low sensitivity in critically ill patients, making imaging examinations the primary method. However, while abdominal CT is considered the gold standard, it is limited by insufficient dynamic monitoring and difficulties in patient transport. Bedside ultrasound plays a significant role in the monitoring of critically ill patients due to its portability, non-invasiveness, and real-time dynamic capabilities. It can assess sources of hemorrhage and infection, quantify the extent of lesions, and monitor hemodynamic changes. Therefore, this study aims to develop a comprehensive ultrasound assessment protocol that covers the peritoneal cavity and posterior peritoneal space. Through a prospective observational study, we aim to validate its sensitivity and specificity in diagnosing pathological accumulations such as intra-abdominal hemorrhage/infection and explore its correlation with patient clinical outcomes.
- Medical subject headings
- Sepsis, Multiple Organ Failure, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational group | Subjectives will undergo abdominal ultrasound examination immediately after receiving an abdominal CT scan.after admission to the ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space
score range from 0-20, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space
score range from 0-20, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Secondary outcomes (18)
Time to initiate enteral nutrition
Time to initiate enteral nutrition after admission to ICU in hours
Measured: up to 3 days after admission to ICU
Intra-abdominal pressure
Intra-abdominal pressure in mmHg
Measured: up to 3 days after admission to ICU
C-reactive protein
C-reactive protein in mg/L
Measured: up to 3 days after admission to ICU
procalcitonin
procalcitonin in ng/L
Measured: up to 3 days after admission to ICU
white blood cell count
white blood cell count
Measured: up to 3 days after admission to ICU
time to achieve enteral nutrition targets
time to achieve enteral nutrition targets in hours
Measured: up to 28 days after admission to ICU
serum albumin
serum albumin in g/L
Measured: up to 28 days after admission to ICU
prealbumin
prealbumin in mg/L
Measured: up to 28 days after admission to ICU
Duration of Continuous Renal Replacement Therapy treatment
Duration of CRRT (Continuous Renal Replacement Therapy) treatment in hours
Measured: up to 28 days after admission to ICU
duration of mechanical ventilation
duration of mechanical ventilation in hours
Measured: up to 28 days after admission to ICU
length of ICU stay
length of ICU stay in days
Measured: up to 28 days after admission to ICU
prognosis
survival or death when transfer out of the ICU
Measured: up to 28 days after admission to ICU
acute physiology and chronic health evaluation II score
score range from 0-71, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Sequential Organ Failure Assessment
score range from 0-15, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Abdominal Gastrointestinal Index score
score range from 0-4, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Abdominal Gastrointestinal Index Ultrasonography Score
score range from 0-10, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Gastrointestinal Ultrasound Scoring score
score range from 0-10, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
semi-quantitative ultrasound score of gastric content
score range from 0-2, higher scores indicate a worse outcome
Measured: up to 3 days after admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Ruijin HospitalThe 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
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634732
- Sponsor's protocol ID
- ZWQ21886-2024-2
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application Value of Quantitative Ultrasound Assessment Plan for Abdominal Cavity Space in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06634732
- Acronym / sponsor ID
- ZWQ21886-2024-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Oct 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.
This is a prospective observational study to observe the diagnostic efficacy of a quantitative ultrasound assessment plan for pathological accumulation in the abdominal cavity space of critically ill patients, and to explore its correlation with patient clinical outcomes.
Detailed description
Intra-abdominal lesions, such as hemorrhage and inflammation/infection, often lead to pathological accumulations, posing serious challenges for critically ill patients. These lesions can rapidly induce intra-abdominal hypertension and organ damage, which may progress to hemorrhagic or septic shock, endangering patients\' lives. Intra-abdominal hemorrhage, especially surgery-related hemorrhage, is difficult to detect early, and existing assessment methods like CT scans have limited applicability in critically ill patients. Intra-abdominal infections account for a high proportion of infections in critically ill patients, with concurrent sepsis or shock having high mortality rates. Despite advancements in critical care medicine, the mortality rate from intra-abdominal infections remains stubbornly high. Accurate assessment of the source and extent of infection is crucial for treatment, yet routine physical examinations have low sensitivity in critically ill patients, making imaging examinations the primary method. However, while abdominal CT is considered the gold standard, it is limited by insufficient dynamic monitoring and difficulties in patient transport. Bedside ultrasound plays a significant role in the monitoring of critically ill patients due to its portability, non-invasiveness, and real-time dynamic capabilities. It can assess sources of hemorrhage and infection, quantify the extent of lesions, and monitor hemodynamic changes. Therefore, this study aims to develop a comprehensive ultrasound assessment protocol that covers the peritoneal cavity and posterior peritoneal space. Through a prospective observational study, we aim to validate its sensitivity and specificity in diagnosing pathological accumulations such as intra-abdominal hemorrhage/infection and explore its correlation with patient clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | –Subjectives will undergo abdominal ultrasound examination immediately after receiving an abdominal CT scan.after admission to the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients in the Department of Critical Care Medicine at Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Key inclusion criteria (3 listed)
- Age \> 18 years old;
- Expected ICU stay ≥ 72 hours;
- Meeting one of the diagnostic criteria for intra-abdominal infection: 1) Single organ infection (such as cholecystitis, appendicitis, diverticulitis, cholangitis, pancreatitis, salpingitis, etc.), which may be accompanied by or without peritonitis, even without perforation; 2) Peritonitis, classified as primary, secondary, or recurrent; 3) Intra-abdominal abscess.
Key exclusion criteria (4 listed)
- Patients with wounds, redness, swelling, bleeding, or other conditions at the abdominal measurement points that prevent ultrasound assessment;
- Patients with intra-abdominal gas accumulation that affects abdominal ultrasound imaging, making ultrasound quantitative scoring impossible;
- Patients who have not undergone abdominal CT examination within 72 hours of ICU admission;
- Patients who do not consent to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space
Time frame: up to 3 days after admission to ICU
score range from 0-20, higher scores indicate a worse outcome
Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space
Time frame: up to 3 days after admission to ICU
score range from 0-20, higher scores indicate a worse outcome
18 secondary outcomes
Time to initiate enteral nutrition
Time frame: up to 3 days after admission to ICU
Intra-abdominal pressure
Time frame: up to 3 days after admission to ICU
C-reactive protein
Time frame: up to 3 days after admission to ICU
procalcitonin
Time frame: up to 3 days after admission to ICU
white blood cell count
Time frame: up to 3 days after admission to ICU
time to achieve enteral nutrition targets
Time frame: up to 28 days after admission to ICU
serum albumin
Time frame: up to 28 days after admission to ICU
prealbumin
Time frame: up to 28 days after admission to ICU
Duration of Continuous Renal Replacement Therapy treatment
Time frame: up to 28 days after admission to ICU
duration of mechanical ventilation
Time frame: up to 28 days after admission to ICU
length of ICU stay
Time frame: up to 28 days after admission to ICU
prognosis
Time frame: up to 28 days after admission to ICU
acute physiology and chronic health evaluation II score
Time frame: up to 3 days after admission to ICU
Sequential Organ Failure Assessment
Time frame: up to 3 days after admission to ICU
Abdominal Gastrointestinal Index score
Time frame: up to 3 days after admission to ICU
Abdominal Gastrointestinal Index Ultrasonography Score
Time frame: up to 3 days after admission to ICU
Gastrointestinal Ultrasound Scoring score
Time frame: up to 3 days after admission to ICU
semi-quantitative ultrasound score of gastric content
Time frame: up to 3 days after admission to ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Sepsis and MODS, run by Ruijin Hospital 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 3 inclusion and 4 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 10 Oct 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?
Contact weiqing Zhang, Ph.D (8618521525300, weiq.zh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space (time frame: up to 3 days after admission to ICU). The study lists 2 primary outcomes in all. 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 10 Oct 2024.