NCT06505512

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

February 28, 2025

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

July 11, 2024

Last Update Submit

February 25, 2025

Conditions

SepsisUrinary Tract Infections

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    upon admission into the ICU, and, 24 and 72 hours afterwards

Study Arms (2)

Survival group

Patients who get better after treatment and eventually survive.

Diagnostic Test: No intervention

Death group

Patients who die within 28 days of hospitalization.

Diagnostic Test: No intervention

Interventions

No interventionDIAGNOSTIC_TEST

No intervention

Death groupSurvival group

Eligibility Criteria

Age14 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingjiang Zheng

Zhangzhou, Fujian, 363000, China

RECRUITING

MeSH Terms

Conditions

SepsisUrinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Hui Jiang, Dr.

    the Ethnics Committee of Zhangzhou Municipal Hospital of Fujian Province

    PRINCIPAL INVESTIGATOR

Central Study Contacts

De Kang, Dr.

CONTACT

+8613960163029cdkant@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 17, 2024

Study Start

January 19, 2024

Primary Completion

February 25, 2025

Study Completion

March 31, 2025

Last Updated

February 28, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)