Quantitative Ultrasound Assessment of Abdominal Cavity Space
- Conditions
- SepsisMODSShock
- Registration Number
- NCT06634732
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space up to 3 days after admission to ICU score range from 0-20, higher scores indicate a worse outcome
Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space up to 3 days after admission to ICU score range from 0-20, higher scores indicate a worse outcome
- Secondary Outcome Measures
Name Time Method Duration of Continuous Renal Replacement Therapy treatment up to 28 days after admission to ICU Duration of CRRT (Continuous Renal Replacement Therapy) treatment in hours
duration of mechanical ventilation up to 28 days after admission to ICU duration of mechanical ventilation in hours
length of ICU stay up to 28 days after admission to ICU length of ICU stay in days
Time to initiate enteral nutrition up to 3 days after admission to ICU Time to initiate enteral nutrition after admission to ICU in hours
Intra-abdominal pressure up to 3 days after admission to ICU Intra-abdominal pressure in mmHg
C-reactive protein up to 3 days after admission to ICU C-reactive protein in mg/L
procalcitonin up to 3 days after admission to ICU procalcitonin in ng/L
white blood cell count up to 3 days after admission to ICU white blood cell count
time to achieve enteral nutrition targets up to 28 days after admission to ICU time to achieve enteral nutrition targets in hours
serum albumin up to 28 days after admission to ICU serum albumin in g/L
prealbumin up to 28 days after admission to ICU prealbumin in mg/L
prognosis up to 28 days after admission to ICU survival or death when transfer out of the ICU
acute physiology and chronic health evaluation II score up to 3 days after admission to ICU score range from 0-71, higher scores indicate a worse outcome
Sequential Organ Failure Assessment up to 3 days after admission to ICU score range from 0-15, higher scores indicate a worse outcome
Abdominal Gastrointestinal Index score up to 3 days after admission to ICU score range from 0-4, higher scores indicate a worse outcome
Abdominal Gastrointestinal Index Ultrasonography Score up to 3 days after admission to ICU score range from 0-10, higher scores indicate a worse outcome
Gastrointestinal Ultrasound Scoring score up to 3 days after admission to ICU score range from 0-10, higher scores indicate a worse outcome
semi-quantitative ultrasound score of gastric content up to 3 days after admission to ICU score range from 0-2, higher scores indicate a worse outcome
Trial Locations
- Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China