VExUS Combined With CVP to Predict Clinical Outcomes in Sepsis Participants

NCT06524622 | Recruiting

• 1 other identifier: SecondYibin
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Acute Kidney Injury

Keywords

VExUS; CVP; acute kidney injury; MAKE30; venous congestion

Outcome Measures

Primary Outcomes (1)

• Clinical outcomes on MAKE30

  MAKE30 is : in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine

  Day 30

Secondary Outcomes (5)

• occurrence of AKI within 7 days

  DAY 7

• length of ICU stay and in-hospital stay

  DAY30

• VExUS score

  DAY3

• CVP value

  DAY3

• All-cause mortality within 30 days

  DAY30

Interventions

Point-of-care ultrasound (POCUS) DEVICE

Point-of-care ultrasound (POCUS) measurements will be performed for all participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the definition of sepsis3.0, Participants with sepsis who are older than 18 years.

You may qualify if:

• Adult participants (age ≥ 18 years) with sepsis upon admission or during their stay in the ICU.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second People's Hospital of Yibin: lead

Study Sites (1)

Point-of-care ultrasound (POCUS)

Yibin, Sichuan, 610000, China

RECRUITING

Related Publications (2)

• Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.

  PMID: 32270297 RESULT

• Spiegel R, Teeter W, Sullivan S, Tupchong K, Mohammed N, Sutherland M, Leibner E, Rola P, Galvagno SM Jr, Murthi SB. The use of venous Doppler to predict adverse kidney events in a general ICU cohort. Crit Care. 2020 Oct 19;24(1):615. doi: 10.1186/s13054-020-03330-6.

  PMID: 33076961 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The ultrasound images of each participant

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury; Hyperemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• lianghai cao, Master's

  Yibin Second People's Hospital, Associate Chief Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xueqian wang

CONTACT

18380722724; 18380722724@163.com

lianghai cao, Master's

CONTACT

13568087080; 370065126@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 29, 2024
• Study Start: July 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (1)