NCT04646629

Brief Summary

  1. 1.Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction
  2. 2.Research center: single center
  3. 3.The Design of the study: Randomized, double-blind, controlled study
  4. 4.The population of the study: The patients over 18 years that met the criteria of sepsis3.0 and with AGI grade II or above are enrolled in the study
  5. 5.Sample size: Enroll 60 patients (30patients in each group)
  6. 6.Interventions: Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment.
  7. 7.The aim of the research: To investigate the effect of electroacupuncture on sepsis-induced intestinal dysfunction.
  8. 8.Outcome# 1) Primary outcome: The intestinal function indicators including: 1) Clinical symptoms: bowel sounds, intra-abdominal pressure, time to first exhaust/defecation, daily tolerable enteral nutrition 2) Intestinal motility indicators: the levels of serum motilin and gastrin 3) Intestinal barrier indicators: the levels of serum diamine oxidase (DAO), D-lactic acid and I-FABP 2)Secondary outcome# Duration of mechanical ventilation in patients with endotracheal intubation on ICU admission; Length of stay in ICU and Length of stay in hospital; 30-day life quality and cognitive function after surgery; All-cause 28-day mortality.
  9. 9.The estimated duration of the study#1-2years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

November 22, 2020

Last Update Submit

November 25, 2020

Conditions

SepsisIntestinal Dysfunction

Keywords

sepsiselectroacupunctureintestinal dysfunction

Outcome Measures

Primary Outcomes (4)

  • The effect on intestinal motility

    Record the serum levels of motilin of the two groups

    an average of one year

  • The effect on intestinal motility

    Record the serum levels of gastrin of the two groups

    an average of 1 year

  • The effect on intestinal barrier

    Record serum levels of DAO of the two groups

    up to 1 year

  • The effect on intestinal barrier

    Record serum levels of I-FABP of the two groups

    up to 12 months

Secondary Outcomes (3)

  • Duration of mechanical ventilation in patients with endotracheal intubation in ICU

    one year

  • Length of stay in hospital

    up to one year

  • All-cause 28-day mortality

    12 months

Study Arms (2)

electroacupuncture treatment

EXPERIMENTAL

Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) isconnected and maintained the end of treatment

Device: electroacupuncture treatment

sham electroacupuncture treatment

SHAM COMPARATOR

sham electroacupuncture treatment participants in the control group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.

Device: sham electroacupuncture treatment

Interventions

electroacupuncture treatmentDEVICE

Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days.After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 \~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment.

electroacupuncture treatment
sham electroacupuncture treatmentDEVICE

Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output, and retained the needle for the same time as treatment group

sham electroacupuncture treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria of sepsis 3.0
  • AGI grade II or above,
  • At least 18 years old
  • Volunteer to participate in this study and sign the informed consent form

You may not qualify if:

  • Patients with bowel dysfunction caused by other diseases or surgical operations
  • Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
  • Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
  • Those who are participating in other drug clinical trials
  • Refuse to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Electroacupuncture Apparatus

Tianjin, China

Location

Related Publications (4)

  • Meng JB, Jiao YN, Zhang G, Xu XJ, Ji CL, Hu MH, Lai ZZ, Zhang M. Electroacupuncture Improves Intestinal Dysfunction in Septic Patients: A Randomised Controlled Trial. Biomed Res Int. 2018 Jun 26;2018:8293594. doi: 10.1155/2018/8293594. eCollection 2018.

    PMID: 30046610BACKGROUND

  • Yoseph BP, Klingensmith NJ, Liang Z, Breed ER, Burd EM, Mittal R, Dominguez JA, Petrie B, Ford ML, Coopersmith CM. Mechanisms of Intestinal Barrier Dysfunction in Sepsis. Shock. 2016 Jul;46(1):52-9. doi: 10.1097/SHK.0000000000000565.

    PMID: 27299587BACKGROUND

  • Li HF, Hu GQ, Liu WW. [Clinical trials of acupuncture of Jiaji (EX-B2) for treatment of gastrointestinal dysfunction in sepsis patients]. Zhen Ci Yan Jiu. 2019 Jan 25;44(1):43-6. doi: 10.13702/j.1000-0607.170579. Chinese.

    PMID: 30773861BACKGROUND

  • Liu H, Zhu J, Ni HB, Hu XX. [Transcutaneous electrical acupoint stimulation for early enteral nutrition tolerance in patients with sepsis of gastrointestinal dysfunction: a multi-center randomized controlled trial]. Zhongguo Zhen Jiu. 2020 Mar 12;40(3):229-33. doi: 10.13703/j.0255-2930.20190426-0003. Chinese.

    PMID: 32270631BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianbo Yu, PhD

    Tianjin Nankai Hospital

    STUDY CHAIR

Central Study Contacts

Yingya Cao, MD

CONTACT

15055324662caoyingya1990@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Study Record Dates

First Submitted

November 22, 2020

First Posted

November 30, 2020

Study Start

November 23, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)