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NCT Number: NCT06634732

Quantitative Ultrasound Assessment of Abdominal Cavity Space

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

Intra-abdominal lesions, such as hemorrhage and inflammation/infection, often lead to pathological accumulations, posing serious challenges for critically ill patients. These lesions can rapidly induce intra-abdominal hypertension and organ damage, which may progress to hemorrhagic or septic shock, endangering patients' lives. Intra-abdominal hemorrhage, especially surgery-related hemorrhage, is difficult to detect early, and existing assessment methods like CT scans have limited applicability in critically ill patients. Intra-abdominal infections account for a high proportion of infections in critically ill patients, with concurrent sepsis or shock having high mortality rates. Despite advancements in critical care medicine, the mortality rate from intra-abdominal infections remains stubbornly high. Accurate assessment of the source and extent of infection is crucial for treatment, yet routine physical examinations have low sensitivity in critically ill patients, making imaging examinations the primary method. However, while abdominal CT is considered the gold standard, it is limited by insufficient dynamic monitoring and difficulties in patient transport. Bedside ultrasound plays a significant role in the monitoring of critically ill patients due to its portability, non-invasiveness, and real-time dynamic capabilities. It can assess sources of hemorrhage and infection, quantify the extent of lesions, and monitor hemodynamic changes. Therefore, this study aims to develop a comprehensive ultrasound assessment protocol that covers the peritoneal cavity and posterior peritoneal space. Through a prospective observational study, we aim to validate its sensitivity and specificity in diagnosing pathological accumulations such as intra-abdominal hemorrhage/infection and explore its correlation with patient clinical outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space

    Time frame: up to 3 days after admission to ICU

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

  2. Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space

    Time frame: up to 3 days after admission to ICU

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

Secondary outcomes

  1. Time to initiate enteral nutrition

    Time frame: up to 3 days after admission to ICU

    Time to initiate enteral nutrition after admission to ICU in hours

  2. Intra-abdominal pressure

    Time frame: up to 3 days after admission to ICU

    Intra-abdominal pressure in mmHg

  3. C-reactive protein

    Time frame: up to 3 days after admission to ICU

    C-reactive protein in mg/L

  4. procalcitonin

    Time frame: up to 3 days after admission to ICU

    procalcitonin in ng/L

  5. white blood cell count

    Time frame: up to 3 days after admission to ICU

    white blood cell count

  6. time to achieve enteral nutrition targets

    Time frame: up to 28 days after admission to ICU

    time to achieve enteral nutrition targets in hours

  7. serum albumin

    Time frame: up to 28 days after admission to ICU

    serum albumin in g/L

  8. prealbumin

    Time frame: up to 28 days after admission to ICU

    prealbumin in mg/L

  9. Duration of Continuous Renal Replacement Therapy treatment

    Time frame: up to 28 days after admission to ICU

    Duration of CRRT (Continuous Renal Replacement Therapy) treatment in hours

  10. duration of mechanical ventilation

    Time frame: up to 28 days after admission to ICU

    duration of mechanical ventilation in hours

  11. length of ICU stay

    Time frame: up to 28 days after admission to ICU

    length of ICU stay in days

  12. prognosis

    Time frame: up to 28 days after admission to ICU

    survival or death when transfer out of the ICU

  13. acute physiology and chronic health evaluation II score

    Time frame: up to 3 days after admission to ICU

    score range from 0-71, higher scores indicate a worse outcome

  14. Sequential Organ Failure Assessment

    Time frame: up to 3 days after admission to ICU

    score range from 0-15, higher scores indicate a worse outcome

  15. Abdominal Gastrointestinal Index score

    Time frame: up to 3 days after admission to ICU

    score range from 0-4, higher scores indicate a worse outcome

  16. Abdominal Gastrointestinal Index Ultrasonography Score

    Time frame: up to 3 days after admission to ICU

    score range from 0-10, higher scores indicate a worse outcome

  17. Gastrointestinal Ultrasound Scoring score

    Time frame: up to 3 days after admission to ICU

    score range from 0-10, higher scores indicate a worse outcome

  18. semi-quantitative ultrasound score of gastric content

    Time frame: up to 3 days after admission to ICU

    score range from 0-2, higher scores indicate a worse outcome

Study contacts

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

weiqing Zhang, Ph.D

CONTACT

[email protected]

8618521525300

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Study on the Application Value of Quantitative Ultrasound Assessment Plan for Abdominal Cavity Space in Critically Ill Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

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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