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The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock patients who are treated with ultrasound-assisted fluid management using change of the inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared with those treated with "usual-care" strategy.
Septic shock (SS) is globally prevalent in with high mortality rate.The current focuses on initial treatment of this condition emphasize on the early recognition, prompt administration of antibiotic, and restoration of hemodynamic with aggressive fluid resuscitation and vasopressor. Regarding the initial fluid therapy, administration of empirical crystalloid at the dose of 30 ml/kg is recommended in the guideline. The ultrasound-assisted management of shock patients has been introduced in the past decade and now is widely used. By using the measurement of inferior vena cava (IVC) diameter change during respiratory phases, physicians can predict the fluid responsiveness in the shock patients and tailor the fluid therapy during the resuscitation.Unfortunately, clinical outcome related to the use of this concept in SS resuscitation has not been well studied. Inadequate resuscitation with fluid therapy is related with higher mortality; however, fluid bolus or positive fluid balance that may result from "too aggressive" fluid administration is also associated with increased mortality in SS patients. The primary aim of this study was to evaluate the 30-day mortality outcome of the SS patients who were treated with ultrasound-assisted fluid management using change of the IVC during respiratory phases in the first 6 hours compared with those who were treated with "usual-care" strategy. The secondary outcomes were to compare the rate of the need for mechanical ventilation (MV) and renal replacement therapy (RRT) as well as the 6-hours lactate clearance and the change in Sequential Organ Failure (SOFA) score in 72 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVC Ultrasound-guided | Experimental | The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. |
|
| Usual care | No Intervention | Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVC Ultrasound-guided | Procedure | IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Mortality | 30-day mortality related to septic shock | 30 day after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of 6-hour Lactate | The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khrongwong Musikatavorn, MD | Emergency Unit, Faculty of Medicine, Chulalongkorn Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medicine Unit, King Chulalongkorn Memorial Hospital | Pathum Wan | Bangkok | 11130 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33856325 | Background | Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IVC Ultrasound-guided | The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte. Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy. |
| FG001 | Usual Care | Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVC Ultrasound-guided | The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte. Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 30-day Mortality | 30-day mortality related to septic shock | Posted | Count of Participants | Participants | 30 day after randomization |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVC Ultrasound-guided | The treating physician will promptly assess the IVC diameter to obtain the collapsibility index (IVCCI) (or distensibility index, IVCDI) of an eligible patient. A previous study showed that IVCCI > 40% were strongly associated with fluid responsiveness. Accordingly, the patient will be given 10 ml/kg of bolus of 0.9% normal saline solution (NSS) each time when the IVCCI > 40% is discovered and serial measurements will be done after each intravenous bolus is achieved until the IVCCI < 40 % during our protocol. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. IVC Ultrasound-guided: IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte. Antibiotics: Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. Vasopressor: The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal replacement therapy | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
This study was conducted with the specific study protocol at a single, tertiary-care hospital. Second, physicians should use cautious clinical judgment or different approaches in different types of patients. The interpersonal variation and sampling position may have affected the consistency of IVC diameter measurement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Khrongwong Musikatavorn | Department of Emergency Medicine, Faculty of Medicine, Chulalongkorn University | +6626494000 | 83058 | kmusikatavorn@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 | Apr 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000890 | Anti-Infective Agents |
| D014662 | Vasoconstrictor Agents |
| D009638 | Norepinephrine |
| D004298 | Dopamine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002317 | Cardiovascular Agents |
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|
| Antibiotics | Drug | Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. |
|
|
| Vasopressor | Drug | The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy. |
|
|
| 6 hours after treatment |
| 6-hour Cumulative Amount of Intravenous Fluid (mL) | Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment. | 6 hours after treatment |
| 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment | Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment. | 72 hours after treatment |
| Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment | The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome. | 72 hours after treatment |
| Protocol Violation |
|
| BG001 | Usual Care | Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patients with infections | Count of Participants | Participants |
|
| OG001 | Usual Care | Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. |
|
|
| Secondary | Percentage Change of 6-hour Lactate | The percentage change in blood lactate at 6 hour after initiation of treatment, calculated by [(Initial blood lactate level at presentation - blood lactate level at 6 hours after treatment)/Initial blood lactate level at presentation] x 100%. The higher positive value means the more relative reduction of blood lactate after treatment from that of initial presentation and indicates a better clinical outcome. | Data of 6-hour lactate was obtained among 100 patients (missing data in one patient) in the Usual care group and 100 patients (missing data in one patient) in the IVC Ultrasound-guided group . | Posted | Median | Inter-Quartile Range | percentage change | 6 hours after treatment |
|
|
|
| Secondary | 6-hour Cumulative Amount of Intravenous Fluid (mL) | Cumulative amount of intravenous fluid (mL) during the first 6 hours after treatment. | Posted | Median | Inter-Quartile Range | mL | 6 hours after treatment |
|
|
|
| Secondary | 72-hour Cumulative Amount of Intravenous Fluid (mL) After Treatment | Cumulative amount of intravenous fluid (mL) during the first 72 hours after treatment. | Data of 72-hour cumulative amount of intravenous fluid was available among 83 patients (missing data in 18 patients; 6 discharge within 72 hours, 5 transfer out, 4 missing records and 3 death within 72 hours) in the Usual care group and 79 patients (missing data in 22 patients, 10 discharge within 72 hours, 4 transfer out, 3 missing records, 5 death within 72 hours) in the IVC Ultrasound-guided group . | Posted | Mean | Inter-Quartile Range | mL | 72 hours after treatment |
|
|
|
| Secondary | Change in Sequential Organ Failure Assessment (SOFA) Score in 72 Hours After Treatment | The change in Sequential Organ Failure Assessment (SOFA) score between the score at initial presentation and 72 hours after treatment, determined by SOFA score at presentation minus the SOFA score at 72 hours after treatment. The possible minimum and maximum value of the change in SOFA score are -24 and +24, respectively. The higher value means the more relative reduction in SOFA score at 72 hours and indicates a better clinical outcome. | Data of 72-hour cumulative amount of intravenous fluid was available among 86 patients (missing data in 15 patients; 6 discharge within 72 hours, 5 transfer out, 1 lack of sufficient information and 3 death within 72 hours) in the Usual care group and 78 patients (missing data in 23 patients, 10 discharge within 72 hours, 4 transfer out, 4 lack of sufficient information, 5 death within 72 hours ) in the IVC Ultrasound-guided group . | Posted | Median | Inter-Quartile Range | Score on a scale | 72 hours after treatment |
|
|
|
| 20 |
| 101 |
| 31 |
| 101 |
| 4 |
| 101 |
| EG001 | Usual Care | Patients will be promptly and empirically treated by 30 ml/kg loading of NSS in this treatment arm. After the NSS bolus, treatment with either the additional intravenous fluid or a vasopressor is given depended on physicians' discretion during the 6-hour study period. Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation. | 19 | 101 | 35 | 101 | 2 | 101 |
| Mechanical ventilator | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |