Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282, China
Location status: Recruiting
NCT Number: NCT05623722
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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Request Info18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510282, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Regional nerve block
Time frame: on the day 7 after enrollment
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.
Time frame: on the day 3 after enrollment
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.
Time frame: on the day 3 and 7 after enrollment
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.
Time frame: on the day 28 after enrolment
All-cause mortality on the day 28 from enrollment
Time frame: on the day 3 and 7 after enrollment
D-lactic acid,intestinal fatty acid binding protein in the serum
Time frame: on the day 3 and 7 after enrollment
The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity.
Time frame: on the day 3 and 7 after enrollment
Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.
Contact information is provided by the study sponsor or research team.
Jing Cai, MD
Other
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury: a Randomized Clinical Trial
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