SepsisNCT06505512
A Study of Enterorenal Syndrome Assessed by Gastrointestinal Ultrasound Combined with Renal Artery Resistance Index
An observational study of Sepsis and Urinary Tract Infections, run by Zhangzhou Municipal Hospital at 1 site in China.
Trial summary
In this study, the patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Sepsis, Urinary Tract Infections
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2024to 31 Mar 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this study, patients who had been admitted into the ICU of our hospital due to sepsis/spetic shock induced by intra-abdominal infections and who had stayed for more than 72 hours.The patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. The cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible.
Who may be able to join
- Patients diagnosed with intra-abdominal infections
- Patients with sepsis or septic shock
Who cannot join
- Patients with open chest or abdominal injury
- Patients with advanced tumor
- Patients with uremia
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qingjiang Zheng
Zhangzhou, Fujian, 363000
Qingjiang Zheng, M.D., 8613799824987, qingjiang233@126.com
About this study
Official title: A Study on the Significance of Joint Evaluation of Gastrointestinal Ultrasound Results and Renal Artery Resistance Index for Assessing the Intestinal-renal Syndrome in Sepsis Patients
In this study, the patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. The cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible. To provide reliable objective basis for clinical decision-making, in order to improve the success rate of rescue.
Read the detailed description
Adult patients admitted to EICU of our hospital who met the diagnostic criteria for sepsis were included in the study. Patients with intra-abdominal sepsis were divided into survival group and death group for case control. Exclusion criteria: open chest and abdomen injury, advanced tumor, uremia, pregnancy. The primary endpoint was survival. Extraction time: ICU (0h), ICU (6h, that is, after fluid resuscitation), ICU (24h), ICU (48h, 08:00 a.m.), ICU (72h, 08:00 a.m.), ICU (120h, 08:00 a.m.); Monitoring indicators: antral cross-section area, colon diameter, colon peristalsis frequency, renal artery resistance index, CVP, ScvO2, IL6, blood lactic acid, blood creatinine, fluid intake, bladder pressure. The primary endpoint of the study was survival rate, and statistical analysis was performed to evaluate the progression of enterorenal syndrome, provide reliable objective basis for subsequent clinical decision-making, and improve the success rate of rescue.
- Conditions
- Sepsis, Urinary Tract Infections
- Being tested
- No intervention
- Medical subject headings
- Sepsis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Survival group | Patients who get better after treatment and eventually survive. Receives: Diagnostic Test: No intervention | |
| Death group | Patients who die within 28 days of hospitalization. Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
superior mesenteric artery resistance index
With the patient in a supine position, ran the probe along the longitudinal section of the abdominal aorta to reveal the long axis of the superior mesenteric artery, and placed the probe 1.0 to 2.0 cm distal of where the superior mesenteric artery starts. The pulsed wave Doppler was used to show the spectrum of blood flow velocity, where the included angle between the bloodstream and the sound beam ranged from 25° to 45°. The waveform was recorded for three cardiac cycles, and the mean value calculated(Figure 1). The normal value of SMARI was between 0.69~0.91
Measured: upon admission into the ICU, and, 24 and 72 hours afterwards
renal artery resistance index
With the patient in a supine position, ran the probe along the longitudinal section of the abdominal aorta to reveal the long axis of the superior mesenteric artery, and placed the probe 1.0 to 2.0 cm distal of where the superior mesenteric artery starts. The pulsed wave Doppler was used to show the spectrum of blood flow velocity, where the included angle between the bloodstream and the sound beam ranged from 25° to 45°. The waveform was recorded for three cardiac cycles, and the mean value calculated(Figure 1). The normal value of SMARI was between 0.69~0.91
Measured: upon admission into the ICU, and, 24 and 72 hours afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start19 Jan 2024
- Primary completion25 Feb 2025 (estimated)
- Study completion31 Mar 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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Jiang, Dr., Principal investigator, the Ethnics Committee of Zhangzhou Municipal Hospital of Fujian Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505512
- Sponsor's protocol ID
- zqj123456
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Significance of Joint Evaluation of Gastrointestinal Ultrasound Results and Renal Artery Resistance Index for Assessing the Intestinal-renal Syndrome in Sepsis Patients
- ClinicalTrials.gov ID
- NCT06505512
- Acronym / sponsor ID
- zqj123456
- Conditions
- Sepsis, Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Zhangzhou Municipal HospitalUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Jul 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.
In this study, the patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. The cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible. To provide reliable objective basis for clinical decision-making, in order to improve the success rate of rescue.
Detailed description
Adult patients admitted to EICU of our hospital who met the diagnostic criteria for sepsis were included in the study. Patients with intra-abdominal sepsis were divided into survival group and death group for case control. Exclusion criteria: open chest and abdomen injury, advanced tumor, uremia, pregnancy. The primary endpoint was survival. Extraction time: ICU (0h), ICU (6h, that is, after fluid resuscitation), ICU (24h), ICU (48h, 08:00 a.m.), ICU (72h, 08:00 a.m.), ICU (120h, 08:00 a.m.); Monitoring indicators: antral cross-section area, colon diameter, colon peristalsis frequency, renal artery resistance index, CVP, ScvO2, IL6, blood lactic acid, blood creatinine, fluid intake, bladder pressure. The primary endpoint of the study was survival rate, and statistical analysis was performed to evaluate the progression of enterorenal syndrome, provide reliable objective basis for subsequent clinical decision-making, and improve the success rate of rescue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survival group | – | Diagnostic Test: No interventionPatients who get better after treatment and eventually survive. |
| Death group | – | Diagnostic Test: No interventionPatients who die within 28 days of hospitalization. |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, patients who had been admitted into the ICU of our hospital due to sepsis/spetic shock induced by intra-abdominal infections and who had stayed for more than 72 hours.The patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. The cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible.
Key inclusion criteria (2 listed)
- Patients diagnosed with intra-abdominal infections
- Patients with sepsis or septic shock
Key exclusion criteria (4 listed)
- Patients with open chest or abdominal injury
- Patients with advanced tumor
- Patients with uremia
- Pregnant women
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 |
|---|---|---|
| No interventionNo intervention | Diagnostic test | Death group, Survival group |
Primary outcome
superior mesenteric artery resistance index
Time frame: upon admission into the ICU, and, 24 and 72 hours afterwards
With the patient in a supine position, ran the probe along the longitudinal section of the abdominal aorta to reveal the long axis of the superior mesenteric artery, and placed the probe 1.0 to 2.0 cm distal of where the superior mesenteric artery starts. The pulsed wave Doppler was used to show the spectrum of blood flow velocity, where the included angle between the bloodstream and the sound beam ranged from 25° to 45°. The waveform was recorded for three cardiac cycles, and the mean value calculated(Figure 1). The normal value of SMARI was between 0.69~0.91
renal artery resistance index
Time frame: upon admission into the ICU, and, 24 and 72 hours afterwards
With the patient in a supine position, ran the probe along the longitudinal section of the abdominal aorta to reveal the long axis of the superior mesenteric artery, and placed the probe 1.0 to 2.0 cm distal of where the superior mesenteric artery starts. The pulsed wave Doppler was used to show the spectrum of blood flow velocity, where the included angle between the bloodstream and the sound beam ranged from 25° to 45°. The waveform was recorded for three cardiac cycles, and the mean value calculated(Figure 1). The normal value of SMARI was between 0.69~0.91
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- 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.
Hui Jiang, Dr. principal investigator
the Ethnics Committee of Zhangzhou Municipal Hospital of Fujian Province
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 Urinary Tract Infections, run by Zhangzhou Municipal 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 2 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 28 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact De Kang, Dr. (+8613960163029, cdkant@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
superior mesenteric artery resistance index (time frame: upon admission into the ICU, and, 24 and 72 hours afterwards). 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 28 Feb 2025.