SepsisNCT06879249
The Effect of CUGP Fluid Management in Patients With Sepsis or Septic Shock
A study testing critical ultrasonography in people with Sepsis, run by Shusheng Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- critical ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 28 Jan 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 years old;
- 2. Estimated length of ICU stay ≥ 24 hours;
- 3. 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.
Who cannot join
- 1. Patients were pregnant woman;
- 2. Patients had acute coronary syndrome;
- 3. Patients had acute pulmonary edema;
- 4. Patients had status asthmatics;
- 5. Patients had malignant arrhythmia;
- 6. Patients had active gastrointestinal bleeding;
Show all 17Show fewer
- 7. Patients had epileptic seizure;
- 8. Patients had drug poisoning;
- 9. Patients had severe burns;
- 10. Patients had contraindications of blood transfusion;
- 11. Patients had intra-abdominal hypertension (intra-abdominal pressure increases continuously ≥ 12mmHg);
- 12. Patients had acute pulmonary embolism;
- 13. Patients had contraindications of leg raising;
- 14. 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;
- 15. Patients or their legal representatives refused active treatment;
- 16. Patients or their legal representatives refused to participate in this study;
- 17. Patients were participating in other interventional clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: The Effect of Critical Ultrasonography Guided Precise Fluid Management in Patients With Sepsis or Septic Shock: A Single-center Randomized Controlled Trial
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.
Read the detailed description
This single-center parallel randomized controlled trial 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. We planned to conduct this single-center trial in the intensive care unit (ICU) of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China. Patients, who are initially diagnosed with sepsis, will be assessed for eligibility immediately upon admission to the ICU. Then, eligible participants will be informed and randomly assigned to one of the two groups: the CUGP group or the usual care group, in a 1:1 ratio using block randomization. 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. The usual care group used conventional hemodynamic monitoring methods for monitoring and decision-making about fluid management. The enrolled patients received either CUGP or usual care fluid management within 72 hours of enrollment in the ICU, and followed by 60 days after randomization. The primary outcome was the 60-day all-cause mortality. The secondary outcomes included SOFA score at 24, 48, and, 72 hours after enrollment, fluid infusion volume, vasoactive drug dosage, incidence of serious adverse events related to fluid management, including new tracheal intubation, severe acute kidney injury, electrolyte disturbance, and organ ischemia (brain, myocardium, gastrointestinal tract, limbs), incidence of complications related to central venous and arterial puncture, acute left heart failure, and pulmonary edema, monitoring failure rates of CUGP group and usual care group, ICU and hospital length of stay, cost of ICU stay/hospitalization. This study adopts a standardized data collection and management system. The study implementer shall fill in the paper or electronic CRF.
- Conditions
- Sepsis
- Being tested
- critical ultrasonography
- Keywords
- sepsis, septic shock, fluid management, critical ultrasonography, volume responsiveness
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
critical ultrasonographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At day 60 after randomization
Secondary outcomes (10)
72-hour SOFA Score
The SOFA (Sequential Organ Failure Assessment) score was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
Measured: At baseline (before randomization), 24 hours, 48 hours, and 72 hours thereafter.
Fluid management for decision
It included monitoring failure rates in the CUGP and usual care groups. In the CUGP group, monitoring failure was recorded if ultrasonographic results conflicted with conventional hemodynamic monitoring or if fluid management based on ultrasonography led to severe complications due to volume inadequacy or overload. Failure was also noted if management based on conventional monitoring improved hemodynamics. Additionally, inability to perform ultrasonography due to factors such as obesity, subcutaneous emphysema, or poor image quality was classified as failure. Patients with monitoring failure and severe complications were promptly transferred to the usual care group for safety. In the usual care group, monitoring failure was recorded if patients could not undergo conventional monitoring or if severe complications occurred following fluid management based on conventional methods. These patients were promptly transferred to the CUGP group to reduce risks.
Measured: Within 72 hours of admission
Complications
It includes the incidence of complications related to central venous and arterial puncture, nosocomial infection, acute left heart failure, pulmonary edema, etc..
Measured: Within 72 hours of admission
Fluid changes with 72 hours
Record the changes in fluid within 72 hours after admission
Measured: Within 72 hours of admission
Dosage of vasopressors changes with 72 hours
Record the changes in dosage of vasopressors within 72 hours after admission
Measured: Within 72 hours of admission
Survival time
The survival time of patients was followed up 60th day after enrollment.
Measured: Follow-up after 60th day after enrollment
Length of ICU stays/hospitalization
The length of ICU stays/hospitalization patients was followed up 60th day after enrollment.
Measured: Follow-up 60th day after enrollment
Cost of ICU stays/hospitalization
The cost of ICU stays/hospitalization patients was followed up 60th day after enrollment.
Measured: Follow-up 60th day after enrollment
Serious adverse events
Serious adverse events occurred after enrollment. Tracheal intubation was defined as new intubation, and non-invasive mechanical ventilation as new usage after enrollment. Severe acute kidney injury was defined as a creatinine increase to three times the baseline or above 354 µmol/L, or the initiation of renal replacement therapy (RRT), excluding patients with chronic kidney failure on long-term dialysis. RRT referred to new use in patients without a history of long-term dialysis. Hypernatremia was defined as serum sodium above 159 mmol/L, and hyperchloremia as serum chloride above 115 mmol/L. Cerebral ischemia/infarction was identified by CT or MRI, while myocardial ischemia/infarction was defined by acute coronary syndrome, ischemic signs on ECG, or the need for coronary intervention or antithrombotic therapy. Intestinal ischemia was confirmed by endoscopy, surgery, or CT angiography, and limb ischemia was indicated by severe mottling and ischemia in the limbs.
Measured: Follow-up 60th day after enrollment
Nosocomial infection during ICU stays
The Nosocomial infection during ICU stays was followed up 60th day after enrollment.
Measured: Follow-up 60th day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Apr 2025
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shusheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shusheng Li, Tongji Hospital
- Investigators
- Shusheng Li, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879249
- Sponsor's protocol ID
- SEPSIS-CUGP
- Other IDs
- YLGX-ZZ-2020001
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD after de-identification can be shared on individual request to the principal investigator at lishusheng@hust.edu.cn.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Critical Ultrasonography Guided Precise Fluid Management in Patients With Sepsis or Septic Shock: A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06879249
- Acronym / sponsor ID
- SEPSIS-CUGP
- Conditions
- Sepsis
- Keywords
- sepsis, septic shock, fluid management, critical ultrasonography, volume responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Shusheng LiUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 17 Mar 2025 (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.
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.
Detailed description
This single-center parallel randomized controlled trial 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. We planned to conduct this single-center trial in the intensive care unit (ICU) of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China. Patients, who are initially diagnosed with sepsis, will be assessed for eligibility immediately upon admission to the ICU. Then, eligible participants will be informed and randomly assigned to one of the two groups: the CUGP group or the usual care group, in a 1:1 ratio using block randomization. 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. The usual care group used conventional hemodynamic monitoring methods for monitoring and decision-making about fluid management. The enrolled patients received either CUGP or usual care fluid management within 72 hours of enrollment in the ICU, and followed by 60 days after randomization. The primary outcome was the 60-day all-cause mortality. The secondary outcomes included SOFA score at 24, 48, and, 72 hours after enrollment, fluid infusion volume, vasoactive drug dosage, incidence of serious adverse events related to fluid management, including new tracheal intubation, severe acute kidney injury, electrolyte disturbance, and organ ischemia (brain, myocardium, gastrointestinal tract, limbs), incidence of complications related to central venous and arterial puncture, acute left heart failure, and pulmonary edema, monitoring failure rates of CUGP group and usual care group, ICU and hospital length of stay, cost of ICU stay/hospitalization. This study adopts a standardized data collection and management system. The study implementer shall fill in the paper or electronic CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUGP group | Experimental | Device: critical ultrasonographyIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Age ≥ 18 years old;
- 2. Estimated length of ICU stay ≥ 24 hours;
- 3. 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.
Key exclusion criteria (17 listed)
- 1. Patients were pregnant woman;
- 2. Patients had acute coronary syndrome;
- 3. Patients had acute pulmonary edema;
- 4. Patients had status asthmatics;
- 5. Patients had malignant arrhythmia;
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 |
|---|---|---|
| critical ultrasonographyIn 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. | Device | CUGP group |
Primary outcome
60-day all-cause mortality
Time frame: At day 60 after randomization
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
10 secondary outcomes
72-hour SOFA Score
Time frame: At baseline (before randomization), 24 hours, 48 hours, and 72 hours thereafter.
Fluid management for decision
Time frame: Within 72 hours of admission
Complications
Time frame: Within 72 hours of admission
Fluid changes with 72 hours
Time frame: Within 72 hours of admission
Dosage of vasopressors changes with 72 hours
Time frame: Within 72 hours of admission
Survival time
Time frame: Follow-up after 60th day after enrollment
Length of ICU stays/hospitalization
Time frame: Follow-up 60th day after enrollment
Cost of ICU stays/hospitalization
Time frame: Follow-up 60th day after enrollment
Serious adverse events
Time frame: Follow-up 60th day after enrollment
Nosocomial infection during ICU stays
Time frame: Follow-up 60th day after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD after de-identification can be shared on individual request to the principal investigator at lishusheng@hust.edu.cn.
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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.
Shusheng Li, PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing critical ultrasonography in people with Sepsis, run by Shusheng Li 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 30 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day all-cause mortality (time frame: At day 60 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.