NCT06879249

The Effect of CUGP Fluid Management in Patients With Sepsis or Septic Shock

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Shusheng Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DEVICE	critical ultrasonography	In the CUGP group, attending physicians utilized a designed fluid management strategy guided by ultrasonographic evaluation of the inner diameter of IVC, ejection fraction (EF) value and passive leg raising-induced changes in VTI (ΔVTI). This 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. Additionally, patients did not preclude the concurrent use of conventional hemodynamic monitoring methods. At each of these time points, attending physicians would make comprehensive decisions on fluid management based on the results of ultrasonographic evaluation, along with other monitoring methods. The researcher recorded the basis of decisions, disposal strategy and outcomes.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-01-28
• Completion: 2026-01-28
• First posted: 2025-03-17
• Last updated: 2026-01-30

Locations

1 site across 1 country: China