Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524622
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
VExUS Combined With CVP to Predict Clinical Outcomes in Sepsis Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Venous Excess Ultrasound Score VExUS Combined With Central Venous Pressure CVP to Predict Clinical Outcomes in Sepsis Participants
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sepsis30 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
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 sepsis30 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
Detailed Description:
Study Title
Association between VExUS Score Combined with CVP and Prediction of Clinical Outcomes in Septic participants A Multicenter Prospective Observational Study
Study Objective
To investigate the relationship between VExUS score CVP within the first 3 days of ICU admission in septic participants and the composite clinical outcome of major kidney adverse events within 30 days MAKE30
Study Hypothesis
The VExUS score and CVP in septic participants are related to the composite clinical outcome of major kidney adverse events within 30 days MAKE 30 and the higher the VExUS score and CVP the greater the risk of MAKE 30
Outcome Measures
Primary Outcome Association between VExUS score CVP and MAKE30 in septic participants
Secondary Outcomes Incidence of AKI within 7 days and all-cause mortality within 30 days in septic participants
Detailed Methods
Case Selection
participants admitted to the ICU of the participating research units between July 2024 and January2025 the participating research units include West China Hospital of Sichuan University Sichuan Provincial Peoples Hospital Mianyang Third Peoples Hospital Affiliated Hospital of Southwest Medical University Longquanyi District First Peoples Hospital Pidu District Peoples Hospital Wenjiang District Peoples Hospital Xindu District Third Peoples HospitalYibin Second Peoples Hospital etc
Data Collection
After the participants were enrolled participants demographic characteristics were collected age gender height weight underlying comorbidities main diagnosis upon ICU admission site of infection microbiological name baseline serum creatinine level etc Collect data on diagnosing sepsis at Day1 0-24hour Day2 24-48hour Day3 48-72hour Day7 and Day30Including Hemodynamic parameters respiratory related indicators neurologic related indicators renal function indicators cardiac markers basic blood tests infection indicators severity scores critical care ultrasound evaluation Occurrence of AKI in day 7 AKI onset time criteria staging Duration of mechanical ventilation use of CRRT vasopressor use length of ICU stay length of hospital stay survival status occurrence of MAKE30
Sample size calculation
Preliminary calculation includes approximately 120 participants
Statistical Analysis Methods
Using SPSS software for statistical analysis Normality test and homogeneity of variance test were conducted for quantitative data Data that conform to normal distribution and homogeneity of variance are represented by mean standard deviation xs Paired t-test is used for comparison between two groups while one-way analysis of variance is used for comparison among multiple groups For quantitative data that do not conform to normal distribution or homogeneity of variance the median interquartile range IQR is used to represent the data and non-parametric tests are used for comparison among multiple groups Count data are expressed as frequency percentage and group comparisons are made using Fishers exact probability test Multiple logistic regression analysis is used to identify risk factors for AKI in sepsis participants Receiver operating characteristic ROC curve analysis is conducted to assess the predictive value Cox regression analysis is used to identify risk factors for mortality in sepsis AKI participants P005 indicates statistical significance
Association between VExUS Score Combined with CVP and Prediction of Clinical Outcomes in Septic participants A Multicenter Prospective Observational Study
Study Objective
To investigate the relationship between VExUS score CVP within the first 3 days of ICU admission in septic participants and the composite clinical outcome of major kidney adverse events within 30 days MAKE30
Study Hypothesis
The VExUS score and CVP in septic participants are related to the composite clinical outcome of major kidney adverse events within 30 days MAKE 30 and the higher the VExUS score and CVP the greater the risk of MAKE 30
Outcome Measures
Primary Outcome Association between VExUS score CVP and MAKE30 in septic participants
Secondary Outcomes Incidence of AKI within 7 days and all-cause mortality within 30 days in septic participants
Detailed Methods
Case Selection
participants admitted to the ICU of the participating research units between July 2024 and January2025 the participating research units include West China Hospital of Sichuan University Sichuan Provincial Peoples Hospital Mianyang Third Peoples Hospital Affiliated Hospital of Southwest Medical University Longquanyi District First Peoples Hospital Pidu District Peoples Hospital Wenjiang District Peoples Hospital Xindu District Third Peoples HospitalYibin Second Peoples Hospital etc
Data Collection
After the participants were enrolled participants demographic characteristics were collected age gender height weight underlying comorbidities main diagnosis upon ICU admission site of infection microbiological name baseline serum creatinine level etc Collect data on diagnosing sepsis at Day1 0-24hour Day2 24-48hour Day3 48-72hour Day7 and Day30Including Hemodynamic parameters respiratory related indicators neurologic related indicators renal function indicators cardiac markers basic blood tests infection indicators severity scores critical care ultrasound evaluation Occurrence of AKI in day 7 AKI onset time criteria staging Duration of mechanical ventilation use of CRRT vasopressor use length of ICU stay length of hospital stay survival status occurrence of MAKE30
Sample size calculation
Preliminary calculation includes approximately 120 participants
Statistical Analysis Methods
Using SPSS software for statistical analysis Normality test and homogeneity of variance test were conducted for quantitative data Data that conform to normal distribution and homogeneity of variance are represented by mean standard deviation xs Paired t-test is used for comparison between two groups while one-way analysis of variance is used for comparison among multiple groups For quantitative data that do not conform to normal distribution or homogeneity of variance the median interquartile range IQR is used to represent the data and non-parametric tests are used for comparison among multiple groups Count data are expressed as frequency percentage and group comparisons are made using Fishers exact probability test Multiple logistic regression analysis is used to identify risk factors for AKI in sepsis participants Receiver operating characteristic ROC curve analysis is conducted to assess the predictive value Cox regression analysis is used to identify risk factors for mortality in sepsis AKI participants P005 indicates statistical significance
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: