NCT06524622 VExUS Combined With CVP to Predict Clinical Outcomes in Sepsis Participants
| NCT ID | NCT06524622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second People's Hospital of Yibin |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-07-01 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and it is a common critical condition in the ICU. Early and timely fluid resuscitation is the cornerstone of sepsis treatment. However, excessive fluid loading can lead to interstitial edema and iatrogenic organ damage, particularly acute kidney injury (AKI). The VExUS grading system is a recently developed system that measures venous congestion through bedside ultrasound by assessing the blood flow waveforms of the portal vein, hepatic vein, and intrarenal veins, as well as the diameter of the inferior vena cava. Similarly, CVP is a commonly used indicator of venous congestion. The objective of this study is to Investigate the association between Venous Excess Ultrasound Score (VExUS), Central Venous Pressure (CVP) during the first three days of ICU admission, and the composite clinical outcome of major adverse kidney events within 30 days (MAKE 30) in sepsis participants. Methods: This study is a prospective, multicenter, observational study that will recruit at least 120 participants across multiple centers. Based on the definition of sepsis3.0, Participants with sepsis who are older than 18 years. Using Doppler ultrasound, Investigator will measure the IVC, HV, PV, and IRV, as well as lung ultrasound scores and cardiac-related parameters at 0-24 hours, 24-48 hours, and 48-72 hours after enrollment. Investigator will receive web-based educational courses, and image acquisition and interpretation will be adjudicated. The primary outcome is the relationship between VExUS score combined with CVP and MAKE 30 in sepsis participants.
Eligibility Criteria
Inclusion Criteria: * Adult participants (age ≥ 18 years) with sepsis upon admission or during their stay in the ICU. Exclusion Criteria: * Age \< 18 years * Participants admitted to the ICU for \< 24 hours * Pregnant or lactating women * Severe renal impairment (defined as baseline estimated glomerular filtration rate \< 15 mL/min or requiring regular dialysis), including causes such as urinary tract obstruction, contrast agents, or nephrotoxic drugs * Liver cirrhosis with portal hypertension * Presence of urinary tract obstruction (which may affect IRVF waveform) * Inability to resolve the primary disease * Participants receiving palliative care * Inability to obtain ultrasound images * Inability to monitor CVP * Refusal of monitoring by participants or their families
Contact & Investigator
lianghai cao, Master's
PRINCIPAL INVESTIGATOR
Yibin Second People's Hospital, Associate Chief Physician
Frequently Asked Questions
Who can join the NCT06524622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06524622 currently recruiting?
Yes, NCT06524622 is actively recruiting participants. Contact the research team at 18380722724@163.com for enrollment information.
Where is the NCT06524622 trial being conducted?
This trial is being conducted at Yibin, China.
Who is sponsoring the NCT06524622 clinical trial?
NCT06524622 is sponsored by The Second People's Hospital of Yibin. The principal investigator is lianghai cao, Master's at Yibin Second People's Hospital, Associate Chief Physician. The trial plans to enroll 120 participants.