Assessing fluid management in sepsis patients using ultrasonography

The Effect of Critical Ultrasonography Guided Precise Fluid Management in Patients With Sepsis or Septic Shock: A Single-center Randomized Controlled Trial

This study is testing if using ultrasound to guide fluid treatment helps people with sepsis recover better than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06879249 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of critical ultrasonography guided precise fluid management (CUGP) on the treatment of patients with sepsis or septic shock. Conducted in the intensive care unit of Tongji Hospital in Wuhan, China, eligible patients will be randomly assigned to either the CUGP group, which receives ultrasonographic assessments at multiple time points, or the usual care group, which follows conventional fluid management practices. The primary outcome is the 60-day all-cause mortality, while secondary outcomes include changes in SOFA scores and fluid management metrics over the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with sepsis who are expected to stay in the ICU for at least 24 hours.

Not a fit: Patients with conditions such as acute coronary syndrome, active gastrointestinal bleeding, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better management of fluid therapy in sepsis patients.

How similar studies have performed: While the use of ultrasonography in fluid management is gaining traction, this specific approach has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 1. Age ≥ 18 years old;
* 2. Estimated length of ICU stay ≥ 24 hours;
* 3. Diagnosis according to the Sepsis 3.0 criteria, which included:
* a. suspected or confirmed infections supported by clinical evidence and/or positive microbiological findings;
* b. the sepsis related organ failure assessment (SOFA) score ≥ 2.

Exclusion Criteria:

* 1. Patients were pregnant woman;
* 2. Patients had acute coronary syndrome;
* 3. Patients had acute pulmonary edema;
* 4. Patients had status asthmatics;
* 5. Patients had malignant arrhythmia;
* 6. Patients had active gastrointestinal bleeding;
* 7. Patients had epileptic seizure;
* 8. Patients had drug poisoning;
* 9. Patients had severe burns;
* 10. Patients had contraindications of blood transfusion;
* 11. Patients had intra-abdominal hypertension (intra-abdominal pressure increases continuously ≥ 12mmHg);
* 12. Patients had acute pulmonary embolism;
* 13. Patients had contraindications of leg raising;
* 14. Patients had cardiac structural or functional abnormalities (left ventricular outflow tract obstruction, moderate-to-severe mitral regurgitation, aortic regurgitation), it would seriously affect the velocity time integral of left ventricular outflow tract;
* 15. Patients or their legal representatives refused active treatment;
* 16. Patients or their legal representatives refused to participate in this study;
* 17. Patients were participating in other interventional clinical trials.

Where this trial is running

Wuhan, Hubei

• Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Shusheng Li, PhD — Tongji Hospital
• Study coordinator: Shusheng Li, PhD

Conditions Sepsis; sepsis, septic shock, fluid management, critical ultrasonography, volume responsiveness