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NCT04646629

Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

Status unknown NA Last updated 30 November 2020
What this trial tests

NA trial testing electroacupuncture treatment in Sepsis in 30 participants. Status unknown.

Timeline
23 November 2020
Primary endpoint
31 December 2021
30 June 2022

Quick facts

Lead sponsorJianbo Yu
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment30
Start date23 November 2020
Primary completion31 December 2021
Estimated completion30 June 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jianbo Yu

Who can join

Adults 18 to 90, any sex, with Sepsis or Intestinal Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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