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

NCT06879249 | Completed DMC

• 2 other identifiers: SEPSIS-CUGPYLGX-ZZ-2020001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis, septic shock, fluid management, critical ultrasonography, volume responsiveness

Outcome Measures

Primary Outcomes (1)

• 60-day all-cause mortality

  It refers to the total number of patients who died from any cause within 60 days of enrollment. It will be described as a rate

  At day 60 after randomization

Secondary Outcomes (10)

• 72-hour SOFA Score

  At baseline (before randomization), 24 hours, 48 hours, and 72 hours thereafter.

• Fluid management for decision

  Within 72 hours of admission

• Complications

  Within 72 hours of admission

• Fluid changes with 72 hours

  Within 72 hours of admission

• Dosage of vasopressors changes with 72 hours

  Within 72 hours of admission

Study Arms (2)

CUGP group

EXPERIMENTAL

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.

Device: critical ultrasonography

usual care group

NO INTERVENTION

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.

Interventions

critical ultrasonography 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.

CUGP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years old;
• \. Estimated length of ICU stay ≥ 24 hours;
• \. 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.

You may not qualify if:

• \. Patients were pregnant woman;
• \. Patients had acute coronary syndrome;
• \. Patients had acute pulmonary edema;
• \. Patients had status asthmatics;
• \. Patients had malignant arrhythmia;
• \. Patients had active gastrointestinal bleeding;
• \. Patients had epileptic seizure;
• \. Patients had drug poisoning;
• \. Patients had severe burns;
• \. Patients had contraindications of blood transfusion;
• \. Patients had intra-abdominal hypertension (intra-abdominal pressure increases continuously ≥ 12mmHg);
• \. Patients had acute pulmonary embolism;
• \. Patients had contraindications of leg raising;
• \. 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;
• \. Patients or their legal representatives refused active treatment;

Sponsors & Collaborators

• Shusheng Li: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Shusheng Li, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: April 1, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available for two years after the publication of the primary outcomes.

Locations

CN (1)