Back to resultsErector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury
Primary Purpose
Sepsis, Acute Gastrointestinal Injury, Organ Dysfunction Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Acute Gastrointestinal Injury, Organ Dysfunction Syndrome, Erector spinae plane block
Eligibility Criteria
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;
Sites / Locations
- Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Erector Spinae Plane Block Group
Arm Description
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.
Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU. 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, dead, or withdraw their consent.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Remission rate of AGI
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
All-cause mortality on the day 28 from enrollment
Full Information
NCT ID
NCT05623722
First Posted
November 13, 2022
Last Updated
January 4, 2023
Sponsor
Jing Cai, MD
Collaborators
Zhongshan People's Hospital, Guangdong, China, Zhongshan Hospital Of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05623722
Brief Title
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury
Official Title
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Cai, MD
Collaborators
Zhongshan People's Hospital, Guangdong, China, Zhongshan Hospital Of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acute Gastrointestinal Injury, Organ Dysfunction Syndrome
Keywords
Sepsis, Acute Gastrointestinal Injury, Organ Dysfunction Syndrome, Erector spinae plane block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Erector Spinae Plane Block Group
Arm Type
Experimental
Arm Description
Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU.
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, dead, or withdraw their consent.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
Regional nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA) score
Description
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 7 after enrollment
Secondary Outcome Measure Information:
Title
SOFA score
Description
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
Title
Remission rate of AGI
Description
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 3 and 7 after enrollment
Title
28-day all-cause mortality
Description
All-cause mortality on the day 28 from enrollment
Time Frame
on the day 28 after enrolment
Other Pre-specified Outcome Measures:
Title
Indexes of intestinal mucosal damage
Description
D-lactic acid，intestinal fatty acid binding protein in the serum
Time Frame
on the day 3 and 7 after enrollment
Title
Gut microbiota diversity
Description
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
Title
Inflammatory indexes
Description
Inflammatory indexes including TNF-α，IL-6，IL-1β，IL-8，IL-10，IL-4 in the serum and feces
Time Frame
on the day 3 and 7 after enrollment
Title
Catecholamine
Description
Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.
Time Frame
on the day 3 and 7 after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Cai, MD
Phone
+86-02062782927
Email
caijing78@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Cai
Organizational Affiliation
Department of Intensive Care Medicine, Zhujiang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Chang, M.D.PhD
Phone
+86-02062782927
Email
changp963@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication are to be shared.
IPD Sharing Time Frame
This are to be provided as a date relative to the time when summary data are published.
IPD Sharing Access Criteria
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.
Learn more about this trial
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury
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