Clinical trial NCT06505512: A Study of Enterorenal Syndrome Assessed by Gastrointestinal Ultrasound Combined with Renal Artery Resistance Index
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Urinary Tract Infections
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 74
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with intra-abdominal infections
* Patients with sepsis or septic shock

Exclusion Criteria:

* Patients with open chest or abdominal injury
* Patients with advanced tumor
* Patients with uremia
* Pregnant women

Primary outcomes:
measure: superior mesenteric artery resistance index
timeFrame: upon admission into the ICU, and, 24 and 72 hours afterwards
measure: renal artery resistance index
timeFrame: upon admission into the ICU, and, 24 and 72 hours afterwards
Secondary outcomes:
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Qingjiang Zheng
state: Fujian
Study officials:
affiliation: the Ethnics Committee of Zhangzhou Municipal Hospital of Fujian Province
name: Hui Jiang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: