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| ID | Type | Description | Link |
|---|---|---|---|
| YLGX-ZZ-2020001 | Other Grant/Funding Number | The China Primary Health Care Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| critical ultrasonography | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At day 60 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (before randomization), 24 hours, 48 hours, and 72 hours thereafter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shusheng Li, PhD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
IPD after de-identification can be shared on individual request to the principal investigator at lishusheng@hust.edu.cn.
IPD and supporting information will be available for two years after the publication of the primary outcomes.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| 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. | 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.. | Within 72 hours of admission |
| Fluid changes with 72 hours | Record the changes in fluid within 72 hours after admission | Within 72 hours of admission |
| Dosage of vasopressors changes with 72 hours | Record the changes in dosage of vasopressors within 72 hours after admission | Within 72 hours of admission |
| Survival time | The survival time of patients was followed up 60th day after enrollment. | 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. | 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. | 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. | Follow-up 60th day after enrollment |
| Nosocomial infection during ICU stays | The Nosocomial infection during ICU stays was followed up 60th day after enrollment. | Follow-up 60th day after enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |