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An open-label randomized controlled trial on the use of electroacupuncture for preventing acute gastrointestinal dysfunction in mechanically ventilated patients with sepsis

An open-label randomized controlled trial on the use of electroacupuncture for preventing acute gastrointestinal dysfunction in mechanically ventilated patients with sepsis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078141
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Standard treatment group:The conventional treatment for sepsis
Standard treatment combined with electroacupuncture group:On the basis of the conventional treatment group, electroacupuncture was added.

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Participants must be at least 18 years of age. 2) Patients admitted to the intensive care unit (ICU) specifically for sepsis without any additional life-threatening injuries are eligible. 3) The expected duration of invasive mechanical ventilation should be equal to or exceed 72 hours. 4) Enteral nutrition administered through oral/nasogastric tube is required, with a projected duration of one week or longer as determined by the attending physician. 5) Informed consent form must be signed by either the patient themselves or an authorized family member who agrees to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Known or suspected acute gastrointestinal obstruction; 2. Those at risk of gastrointestinal perforation; 3. History of peptic ulcer disease; 4. Suffering from Crohn's disease; 5. Suffering from Ogilvie syndrome; 6. In the case of acute diverticulitis; 7. Presence of infiltrative gastrointestinal tumors; 8. In the case of recurrent or advanced ovarian cancer with peritoneal metastasis; 9. Individuals who have recently experienced abdominal trauma that may lead to a risk of gastrointestinal perforation; 10. Other primary diseases are gastrointestinal diseases; 11. Those who have had myocardial infarction in the past 6 months and have obvious clinical manifestations related to congestive cardiovascular system, with QT interval =500 milliseconds; 12. Family members sign consent for conservative treatment measures for the patient; 13. Known pregnancy and/or breastfeeding individuals; 14. Patients with severe liver cirrhosis classified as Child Pugh grade C; 15. Individuals who have suffered one or more life-threatening events; 16. Those who participated in other clinical trials in the previous month, including ongoing trial subjects. 17. After cardiac pacemaker surgery or those with metal objects (such as prostheses, etc.) inside their body.

Design outcomes

Primary

MeasureTime frame
Incidence of S-AGI ;

Secondary

MeasureTime frame
Severity Classification of S-AGI;Gastric retention;Abdominal circumference;Bowel sounds;Number of days tolerating daily feeding target;Proportion of patients receiving erythromycin and/or metoclopramide for feeding intolerance management;Number of patients receiving one or more rectal laxatives for constipation management;Plasma pre-albumin levels;Incidence of S-PICS;Duration of invasive mechanical ventilation in days;ICU length of stay in days;Mortality rate in day 7;Mortality rate in day 28 ;Motilin;Gastrin;Adverse event;

Countries

China

Contacts

Public ContactJian Xu

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

xujian@gzucm.edu.cn+86 20 3931 8526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026