SepsisNCT06524622
VExUS Combined With CVP to Predict Clinical Outcomes in Sepsis Participants
An observational study of Sepsis and Acute Kidney Injury, run by The Second People's Hospital of Yibin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury
- What is being tested?
- Point-of-care ultrasound (POCUS)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Based on the definition of sepsis3.0, Participants with sepsis who are older than 18 years.
Who may be able to join
- Adult participants (age ≥ 18 years) with sepsis upon admission or during their stay in the ICU.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Point-of-care ultrasound (POCUS)
Yibin, Sichuan, 610000
XueQian Wang, 18380722724, 18380722724@163.com
About this study
Official title: Venous Excess Ultrasound Score (VExUS) Combined With Central Venous Pressure (CVP) to Predict Clinical Outcomes in Sepsis Participants
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.
Read more
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.
Read the 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 ,January，2025 (the participating research units include: West China Hospital of Sichuan University, Sichuan Provincial People's Hospital, Mianyang Third People's Hospital, Affiliated Hospital of Southwest Medical University, Longquanyi District First People's Hospital, Pidu District People's Hospital, Wenjiang District People's Hospital, Xindu District Third People's Hospital,Yibin Second People's 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 Day30(Including 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 (x±s). 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 Fisher's 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. P<0.05 indicates statistical significance.
- Conditions
- Sepsis, Acute Kidney Injury
- Being tested
- Point-of-care ultrasound (POCUS)
- Keywords
- VExUS, CVP, acute kidney injury, MAKE30, venous congestion
- Medical subject headings
- Sepsis, Acute Kidney Injury, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasound (POCUS)Device
Point-of-care ultrasound (POCUS) measurements will be performed for all participants
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 30
Secondary outcomes (5)
occurrence of AKI within 7 days
Incidence of AKI from enrollment to 7 days post-enrollment
Measured: DAY 7
length of ICU stay and in-hospital stay
average length of ICU stay and in-hospital stay will be compared
Measured: DAY30
VExUS score
difference of the VExUS score at day 1, 2, 3 day between groups.Higher score means more illness.
Measured: DAY3
CVP value
difference of the CVP value at day 1, 2, 3 day between groups.Higher score means more illness.
Measured: DAY3
All-cause mortality within 30 days
All-cause mortality within 30 days
Measured: DAY30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Yibin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xueqian, The Second People's Hospital of Yibin
- Investigators
- lianghai cao, Master's, Principal investigator, Yibin Second People's Hospital, Associate Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524622
- Sponsor's protocol ID
- SecondYibin
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
Publications
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.
PubMed 32270297Spiegel 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.
PubMed 33076961
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Excess Ultrasound Score (VExUS) Combined With Central Venous Pressure (CVP) to Predict Clinical Outcomes in Sepsis Participants
- ClinicalTrials.gov ID
- NCT06524622
- Acronym / sponsor ID
- SecondYibin
- Conditions
- Sepsis, Acute Kidney Injury
- Keywords
- VExUS, CVP, acute kidney injury, MAKE30, venous congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Second People's Hospital of YibinUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ,January，2025 (the participating research units include: West China Hospital of Sichuan University, Sichuan Provincial People's Hospital, Mianyang Third People's Hospital, Affiliated Hospital of Southwest Medical University, Longquanyi District First People's Hospital, Pidu District People's Hospital, Wenjiang District People's Hospital, Xindu District Third People's Hospital,Yibin Second People's 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 Day30(Including 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 (x±s). 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 Fisher's 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. P<0.05 indicates statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on the definition of sepsis3.0, Participants with sepsis who are older than 18 years.
Key inclusion criteria (1 listed)
- Adult participants (age ≥ 18 years) with sepsis upon admission or during their stay in the ICU.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasound (POCUS)Point-of-care ultrasound (POCUS) measurements will be performed for all participants | Device | – |
Primary outcome
Clinical outcomes on MAKE30
Time frame: Day 30
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
5 secondary outcomes
occurrence of AKI within 7 days
Time frame: DAY 7
length of ICU stay and in-hospital stay
Time frame: DAY30
VExUS score
Time frame: DAY3
CVP value
Time frame: DAY3
All-cause mortality within 30 days
Time frame: DAY30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Results publication: PubMed 32270297Beaubien-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.
- Results publication: PubMed 33076961Spiegel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lianghai cao, Master's principal investigator
Yibin Second People's Hospital, Associate Chief Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Kidney Injury, run by The Second People's Hospital of Yibin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xueqian wang (18380722724, 18380722724@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes on MAKE30 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06524622, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.