Clinical trial NCT06879249: The Effect of CUGP Fluid Management in Patients With Sepsis or Septic Shock
Official title: The Effect of Critical Ultrasonography Guided Precise Fluid Management in Patients With Sepsis or Septic Shock: A Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: sepsis, septic shock, fluid management, critical ultrasonography, volume responsiveness
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess whether procedural critical ultrasonography guided precise fluid management (CUGP) can affect the clinical fluid management strategy and improve the outcomes of patients with sepsis or septic shock.

Detailed description: This single-center parallel randomized controlled trial aims to assess whether procedural critical ultrasonography guided precise fluid management (CUGP) can affect the clinical fluid management strategy and improve the outcomes of patients with sepsis or septic shock. We planned to conduct this single-center trial in the intensive care unit (ICU) of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China. Patients, who are initially diagnosed with sepsis, will be assessed for eligibility immediately upon admission to the ICU. Then, eligible participants will be informed and randomly assigned to one of the two groups: the CUGP group or the usual care group, in a 1:1 ratio using block randomization. In the CUGP group, ultrasonographic assessment was performed by a team of trained critical ultrasonography physicians at enrollment, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours thereafter, respectively. The usual care group used conventional hemodynamic monitoring methods for monitoring and decision-making about fluid management. The enrolled patients received either CUGP or usual care fluid management within 72 hours of enrollment in the ICU, and followed by 60 days after randomization. The primary outcome was the 60-day all-cause mortality. The secondary outcomes included SOFA score at 24, 48, and, 72 hours after enrollment, fluid infusion volume, vasoactive drug dosage, incidence of serious adverse events related to fluid management, including new tracheal intubation, severe acute kidney injury, electrolyte disturbance, and organ ischemia (brain, myocardium, gastrointestinal tract, limbs), incidence of complications related to central venous and arterial puncture, acute left heart failure, and pulmonary edema, monitoring failure rates of CUGP group and usual care group, ICU and hospital length of stay, cost of ICU stay/hospitalization. This study adopts a standardized data collection and management system. The study implementer shall fill in the paper or electronic CRF.

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.

Primary outcomes:
measure: 60-day all-cause mortality
timeFrame: At day 60 after randomization
Secondary outcomes:
measure: 72-hour SOFA Score
timeFrame: At baseline (before randomization), 24 hours, 48 hours, and 72 hours thereafter.
measure: Fluid management for decision
timeFrame: Within 72 hours of admission
measure: Complications
timeFrame: Within 72 hours of admission
measure: Fluid changes with 72 hours
timeFrame: Within 72 hours of admission
measure: Dosage of vasopressors changes with 72 hours
timeFrame: Within 72 hours of admission
measure: Survival time
timeFrame: Follow-up after 60th day after enrollment
measure: Length of ICU stays/hospitalization
timeFrame: Follow-up 60th day after enrollment
measure: Cost of ICU stays/hospitalization
timeFrame: Follow-up 60th day after enrollment
measure: Serious adverse events
timeFrame: Follow-up 60th day after enrollment
measure: Nosocomial infection during ICU stays
timeFrame: Follow-up 60th day after enrollment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shusheng Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: