Quantitative Ultrasound Assessment of Abdominal Cavity Space

NCT06634732 | Not Yet Recruiting

• 1 other identifier: ZWQ21886-2024-2
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; MODS; Shock

Outcome Measures

Primary Outcomes (2)

• Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space

  score range from 0-20, higher scores indicate a worse outcome

  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

  up to 3 days after admission to ICU

Secondary Outcomes (18)

• Time to initiate enteral nutrition

  up to 3 days after admission to ICU

• Intra-abdominal pressure

  up to 3 days after admission to ICU

• C-reactive protein

  up to 3 days after admission to ICU

• procalcitonin

  up to 3 days after admission to ICU

• white blood cell count

  up to 3 days after admission to ICU

Study Arms (1)

observational group

Subjectives will undergo abdominal ultrasound examination immediately after receiving an abdominal CT scan.after admission to the ICU.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients in the Department of Critical Care Medicine at Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Sepsis; Multiple Organ Failure; Shock

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

weiqing Zhang, Ph.D

CONTACT

8618521525300; weiq.zh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-09

Locations

CN (1)