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NCT Number: NCT06505512

A Study of Enterorenal Syndrome Assessed by Gastrointestinal Ultrasound Combined with Renal Artery Resistance Index

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.

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Key information

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qingjiang Zheng

Zhangzhou, Fujian, 363000, China

Location status: Recruiting

Location contact

Qingjiang Zheng, M.D.

CONTACT

[email protected]

8613799824987

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Diagnostic Test

No intervention

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

De Kang, Dr.

CONTACT

[email protected]

+8613960163029

Sponsors and collaborators

Lead sponsor

Zhangzhou Municipal Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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