Back to resultsElectroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS
Primary Purpose
Sepsis, Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture treatment
sham electroacupuncture treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
Inclusion Criteria: Males or females over the age of 18; Diagnosis meets SPESIS 3 criteria for sepsis; The diagnosis meets the Berlin diagnostic criteria for ARDS; ARDS was diagnosed within 48h; Capable of understanding the purpose and risk of the study; Patients or proxy must give written informed consent before any assessment is performed. Exclusion Criteria: ARDS was diagnosed 48h later; Pregnancy, lactation or perinatal period; malignant tumor; Severe liver failure or kidney failure; Predicted mortality risk of patients within 24h>80%; Severe end-stage lung disease; ECMO patients are undergoing implementation; HIV seropositive or Syphilis seropositive; Any clinical-relevant condition that might affect study participation and/or study results; Participation in any other intervention trial; Unwillingness or inability to following the study protocol in the investigators opinion.
Sites / Locations
- Tianjin Nankai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electroacupuncture (EA)
Sham electroacupuncture (SHAM-EA)
Arm Description
The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.
No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.
Outcomes
Primary Outcome Measures
Serum levels of Lipoxin A4 (LXA4)
Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
Secondary Outcome Measures
LXA4 levels in BALF
LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.
Ventilation-free days
The number of days the patient was alive and free of mechanical ventilation (MV)
Oxygenation index
The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Ventilator-provided positive end-expiratory pressure (PEEP)
Ventilator parameter
plateau pressure
Ventilator parameter
tidal volume
Ventilator parameter
Inflammation biomarkers Inflammation levels
Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
Sequential Organ-Failure Assessment (SOFA) score
The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
Rate of electroacupuncture-related adverse events
Rate of electroacupuncture-related adverse events
Full Information
NCT ID
NCT06006325
First Posted
August 16, 2023
Last Updated
September 4, 2023
Sponsor
Tianjin Nankai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06006325
Brief Title
Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS
Official Title
Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Nankai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with ARDS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture (EA)
Arm Type
Experimental
Arm Description
The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.
Arm Title
Sham electroacupuncture (SHAM-EA)
Arm Type
Sham Comparator
Arm Description
No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.
Intervention Type
Device
Intervention Name(s)
electroacupuncture treatment
Intervention Description
Patients received acupuncture on both sides of the Zusanli (ST36) acupuncture points, and after "Deqi ", the needle was connected to an electro-acupuncture device (Hwato, Suzhou Medical ). The EA stimulation lasted for 30 min.
Intervention Type
Device
Intervention Name(s)
sham electroacupuncture treatment
Intervention Description
The participants in the SHAM-EA group performed shallow punctures at the bilateral non-acupuncture points, did not perform the "Deqi" operation, and were connected to the electroacupuncture stimulator but not energized.
Primary Outcome Measure Information:
Title
Serum levels of Lipoxin A4 (LXA4)
Description
Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
LXA4 levels in BALF
Description
LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.
Time Frame
Up to 7 days
Title
Ventilation-free days
Description
The number of days the patient was alive and free of mechanical ventilation (MV)
Time Frame
Up to 28 days
Title
Oxygenation index
Description
The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Time Frame
Up to 7 days
Title
Ventilator-provided positive end-expiratory pressure (PEEP)
Description
Ventilator parameter
Time Frame
Up to 7 days
Title
plateau pressure
Description
Ventilator parameter
Time Frame
Up to 7 days
Title
tidal volume
Description
Ventilator parameter
Time Frame
Up to 7 days
Title
Inflammation biomarkers Inflammation levels
Description
Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
Time Frame
Up to 7 days
Title
Sequential Organ-Failure Assessment (SOFA) score
Description
The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
Time Frame
Up to 7 days
Title
Rate of electroacupuncture-related adverse events
Description
Rate of electroacupuncture-related adverse events
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females over the age of 18;
Diagnosis meets SPESIS 3 criteria for sepsis;
The diagnosis meets the Berlin diagnostic criteria for ARDS;
ARDS was diagnosed within 48h;
Capable of understanding the purpose and risk of the study;
Patients or proxy must give written informed consent before any assessment is performed.
Exclusion Criteria:
ARDS was diagnosed 48h later;
Pregnancy, lactation or perinatal period;
malignant tumor;
Severe liver failure or kidney failure;
Predicted mortality risk of patients within 24h>80%;
Severe end-stage lung disease;
ECMO patients are undergoing implementation;
HIV seropositive or Syphilis seropositive;
Any clinical-relevant condition that might affect study participation and/or study results;
Participation in any other intervention trial;
Unwillingness or inability to following the study protocol in the investigators opinion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianbo Yu, MD
Phone
+8615344422323
Email
30717008@nankai.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianbo Yu, MD
Organizational Affiliation
Tianjin Nankai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Nankai Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuan Dong, Professor
Phone
（022）27435008
Ext
（022）27435027
Email
dongshuan@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34646018
Citation
Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13. Erratum In: Nature. 2022 Jan;601(7893):E9.
Results Reference
background
PubMed Identifier
23480440
Citation
Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
Results Reference
background
PubMed Identifier
29937192
Citation
Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.
Results Reference
background
PubMed Identifier
31573637
Citation
Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825. Erratum In: JAMA. 2020 Jan 28;323(4):379.
Results Reference
background
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Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS
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