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

NCT ID: NCT06879249

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-01-28

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CUGP group

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.

Group Type: EXPERIMENTAL

critical ultrasonography

Intervention Type: DEVICE

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.

usual care group

The usual care group used conventional hemodynamic monitoring methods for monitoring and decision-making about fluid management. Records were made at enrollment, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours thereafter, respectively.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shusheng Li

OTHER

Sponsor Role: lead

Responsible Party

Shusheng Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shusheng Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

YLGX-ZZ-2020001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SEPSIS-CUGP

Identifier Type: -

Identifier Source: org_study_id