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| Name | Class |
|---|---|
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Zhongshan Hospital Of Traditional Chinese Medicine | OTHER |
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This study is a prospective, multicenter, parallel-group, open-label, randomized controlled clinical trial. Sepsis is defined as organ dysfunction induced by infections. And sepsis and gastrointestinal injury can be the leading cause for each other. Our previous study showed erector spinae plane block improved the organ dysfunctions in patients with AGI. The aim of the clinical trial is to investigate erector pinae plane block improves the organ dysfunction in septic patients with acute gastrointestinal injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU. The interventions end on day 7 or cease when the patients are discharged from the ICU, dead, or withdraw their consent. | |
| Erector Spinae Plane Block Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block | Procedure | Ultrasound-guided erector spinae plane block is performed at thoracic (T) level 8. An 18F catheter is placed on both sides of the thoracic vertebra deep into the erector spinae, and a bolus of 20 ml of 0.375% ropivacaine is administered bilaterally. Then, a continuous infusion of 20 ml of 0.375% ropivacaine on each side is followed at a rate of 2 ml/h every 12 hours. The intervention ends on day 7 or ceases when the patient is discharged from the ICU, died, or withdrew their consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. The mininum value is 0 score, and the maximum value is 24 scores. The higher scores mean a worse outcome. | on the day 7 after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. The mininum value is 0 score, and the maximum value is 24 scores. The higher scores mean a worse outcome. | on the day 3 after enrollment |
| Remission rate of AGI |
| Measure | Description | Time Frame |
|---|---|---|
| Indexes of intestinal mucosal damage | D-lactic acid，intestinal fatty acid binding protein in the serum | on the day 3 and 7 after enrollment |
| Gut microbiota diversity | The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Cai, MD | Contact | +86-02062782927 | caijing78@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Cai | Department of Intensive Care Medicine, Zhujiang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University | Recruiting | Guangzhou | Guangdong | 510282 | China |
all IPD that underlie results in a publication are to be shared.
This are to be provided as a date relative to the time when summary data are published.
The data will be made available upon reasonable request by the corresponding author. A proposal with a detailed description of the study objectives and a plan for statistical analysis will be required for the evaluation of the reasonability of requests. Additional materials may also be required during the process of request evaluation. The data of deidentified participants will be provided after approval by the corresponding authors and the Zhujiang Hospital of Southern Medical University.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Participants are assigned to two groups in parallel. All patients in both groups receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU.For patients in the erector spinae plane block group, ultrasound-guided erector spinae plane block is performed at thoracic (T) level 8. An 18F catheter is placed on both sides of the thoracic vertebra deep into the erector spinae, and a bolus of 20 ml of 0.375% ropivacaine is administered bilaterally. Then, a continuous infusion of 20 ml of 0.375% ropivacaine on each side is followed at a rate of 2 ml/h every 12 hours. The interventions end on day 7 or cease when the patients are discharged from the ICU, died, or withdrew their consent.
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The remission of AGI is defined as a decrease of more than one grade in AGI grades. The remission rate is the percentage of remission in the same cohort. |
| on the day 3 and 7 after enrollment |
| 28-day all-cause mortality | All-cause mortality on the day 28 from enrollment | on the day 28 after enrolment |
| on the day 3 and 7 after enrollment |
| Catecholamine | Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum. | on the day 3 and 7 after enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |