Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJing Cai, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Erector spinae plane block
Procedure/SurgeryUltrasound-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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Erector Spinae Plane Block GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
on the day 7 after enrollmentSecondary outcomes
1
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.
Time frame
on the day 3 after enrollment2
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.
Time frame
on the day 3 and 7 after enrollment3
28-day all-cause mortality
All-cause mortality on the day 28 from enrollment
Time frame
on the day 28 after enrolmentOther outcomes
1
Indexes of intestinal mucosal damage
D-lactic acid，intestinal fatty acid binding protein in the serum
Time frame
on the day 3 and 7 after enrollment2
Gut microbiota diversity
The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity.
Time frame
on the day 3 and 7 after enrollment3
Catecholamine
Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.
Time frame
on the day 3 and 7 after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jing Cai, MD
Lead sponsor
Zhujiang Hospital
Sponsor institution
Zhongshan People's Hospital, Guangdong, China
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov