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SepsisNCT04646629

Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

A study testing electroacupuncture treatment in people with Sepsis and Intestinal Dysfunction, run by Jianbo Yu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction 2. Research center: single center 3. The Design of the study: Randomized, double-blind, controlled study 4. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sepsis, Intestinal Dysfunction
What is being tested?
electroacupuncture treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
23 Nov 2020to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Yingya Cao, MD contact

15055324662

caoyingya1990@126.com

China1 site

  • Electroacupuncture Apparatus

    Tianjin

    Yingya Cao, MD, 15055324662, caoyingya1990@126.com

Other trials in China

About this study

Official title: Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction: a Prospective, Double-blind, Randomized Controlled Trial

  1. Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction
  2. Research center: single center
  3. The Design of the study: Randomized, double-blind, controlled study
  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. Sample size: Enroll 60 patients (30patients in each group)
  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. 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.
  7. The aim of the research: To investigate the effect of electroacupuncture on sepsis-induced intestinal dysfunction.
  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. The estimated duration of the study#1-2years.
Read the detailed description

This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, ST36 (Zusanli) and ST37 (Shangjuxu) were selected for electroacupuncture treatment, accompanied with evaluating the effects on intestinal function in septic patients. Meanwhile, the blood biochemical indexes such as heme oxygenase-1(HO-1), PTEN induced putative kinase 1(PINK1), polo-like kinase 1(PLK1) and interleukin-6 are detected. To clarify the effect of electroacupuncture on sepsis-induced intestinal dysfunction is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

Being tested
electroacupuncture treatment, sham electroacupuncture treatment
Keywords
sepsis, electroacupuncture, intestinal dysfunction
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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

Study groups in NCT04646629
Study groupRoleWhat they receive
electroacupuncture treatmentExperimentalParticipants 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
Receives: Device: electroacupuncture treatment
sham electroacupuncture treatmentSham comparatorsham 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.
Receives: Device: sham electroacupuncture treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect on intestinal motility

    Record the serum levels of motilin of the two groups

    Measured: an average of one year

  2. The effect on intestinal motility

    Record the serum levels of gastrin of the two groups

    Measured: an average of 1 year

  3. The effect on intestinal barrier

    Record serum levels of DAO of the two groups

    Measured: up to 1 year

  4. The effect on intestinal barrier

    Record serum levels of I-FABP of the two groups

    Measured: up to 12 months

Secondary outcomes (3)

  1. Duration of mechanical ventilation in patients with endotracheal intubation in ICU

    Duration of mechanical ventilation and endotracheal intubation in ICU

    Measured: one year

  2. Length of stay in hospital

    ICU stay time and hospitalization time

    Measured: up to one year

  3. All-cause 28-day mortality

    All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2020
  2. Study start23 Nov 2020 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04646629
Sponsor's protocol ID
NKYY_YXKT_IRB_2020_071_01
Status last verified
Nov 2020
First submitted
22 Nov 2020
Last updated
30 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30046610

  • 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.

    PubMed 27299587

  • 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.

    PubMed 30773861

  • 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.

    PubMed 32270631

Questions about this trial

What is this clinical trial studying?

A study testing electroacupuncture treatment in people with Sepsis and Intestinal Dysfunction, run by Jianbo Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yingya Cao, MD (15055324662, caoyingya1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect on intestinal motility (time frame: an average of one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646629, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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