Acute Gastrointestinal Injury, Organ Dysfunction Syndrome, Sepsis
Conditions
Keywords
Sepsis, Acute Gastrointestinal Injury, Organ Dysfunction Syndrome, Erector spinae plane block
Brief summary
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.
Interventions
PROCEDUREErector spinae plane block
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.
Sponsors
Zhongshan People's Hospital, Guangdong, China
Zhongshan Hospital Of Traditional Chinese Medicine
Jing Cai, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Septic patients with acute gastrointestinal injury grade II or III; * Age over 18 years; * Expected to stay in the ICU for at least 3 days or longer;
Exclusion criteria
* Mean arterial pressure less than 65 mmHg after fluid resuscitation, or requirement for an intravenous norepinephrine dose of greater than 0.5 µg/kg/min to maintain a normal mean arterial pressure; * Heart rates less than 50 beats/min, or concomitant with moderate-to-severe atrioventricular block without a pacemaker; * Contraindications for erector spinae plane blocks, including infection of the puncture site, spinal diseases or immobilization; * Primary gastrointestinal disorders requiring a surgical procedure, such as mechanical intestinal obstruction, massive gastrointestinal hemorrhage, and gastrointestinal perforation; * Gastrointestinal operation within one week before enrollment; * Neuromuscular disorders; * Coagulation abnormalities：activated prothrombin time or prothrombin time is prolonged with 2 folds, or platelet count less than 50×109/L; * End-stage malignant tumor or cachexia; * History of allergy to amide anesthetics; * Known pregnancy;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score | 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. |
| Remission rate of AGI | 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. |
| 28-day all-cause mortality | on the day 28 after enrolment | All-cause mortality on the day 28 from enrollment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Catecholamine | on the day 3 and 7 after enrollment | Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum. |
| Indexes of intestinal mucosal damage | on the day 3 and 7 after enrollment | D-lactic acid，intestinal fatty acid binding protein in the serum |
| Gut microbiota diversity | on the day 3 and 7 after enrollment | The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity. |
Countries
China
Contacts
Primary ContactJing Cai, MD
Outcome results
None listed