Clinical trial NCT06207461: Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery
Official title: Effects of Traditional Chinese Acupoint Massage on Gastrointestinal Function Recovery of ICU Patients: a Single-center, Prospective, Non-blind, Randomized Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Traditional Chinese Acupoint Message
Intestinal Barrier
Gastrointestinal Dysfunction
Keywords: Acupoint massage
Gastrointestinal dysfunction
Gastrointestinal function recovery
Intensive care unit
Intestinal barrier
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients at high risk of malnutrition due to gastrointestinal functional impairment caused by medical diseases in the ICU, and AGI grade I-II or NRS 2002 score ≥3.

Brief summary: Patients in the intensive care unit (ICU) are often at risk of gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction was associated with poor clinical outcomes, including prolonged mechanical ventilation, prolonged ICU stay and increased 90-day mortality.

There have been some clinical studies investigating the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on gastrointestinal function recovery. Gastrointestinal dysfunction could be improved by stimulating single acupoint or combining multiple acupoints, and the effects of combined stimulation of multiple acupoints was better for the improvement of gastrointestinal dysfunction.

This project aims to study the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on the 28-day survival, and the gastrointestinal function recovery in critically ill patients with with gastrointestinal dysfunction caused by medical diseases and critically ill patients with high risk of malnutrition in ICU, and to observe their effects on the recovery of gastrointestinal barrier function by measuring the serum intestinal fatty acid binding protein (iFABP), citrulline, diamine oxidase (DAO) and D-lactic acid. Studies have shown that serum iFABP, citrulline, DAO and D-lactic acid could reflect the intestinal barrier function of the patients.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;
2. Patients with high risk of malnutrition due to gastrointestinal dysfunction caused by medical diseases, and AGI score Ⅰ-Ⅱ or NRS 2002 score ≥3 points;
3. Patients with hospital stay longer than 120 hours;
4. Willing to participate in this trial.

Exclusion Criteria:

1. Patients with abdominal open trauma;
2. Defects, infections or lesions in the skin near the acupoints；
3. Patients with abdominal tumor or large amount of abdominal fluid;
4. Patients with AGI score Ⅲ or above;
5. Pregnant patients;
6. Patients with Child-Pugh grade B and grade C liver function
7. Unable or unwilling to provide informed consent or poor compliance.

Primary outcomes:
measure: 28-day survival rate (%)
timeFrame: Up to 4 weeks
measure: Ultrasound assessment of gastrointestinal function: ACF (times/min)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Ultrasound assessment of gastrointestinal function: ACA (%)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Ultrasound assessment of gastrointestinal function: MI
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Ultrasound assessment of gastrointestinal function: GET (min)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Ultrasound assessment of gastrointestinal function: intestinal wall thickness (mm)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Ultrasound assessment of gastrointestinal function: intestinal diameter (cm)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Ultrasound assessment of gastrointestinal function: intestinal motility
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Secondary outcomes:
measure: Daily amount of enteral nutrition feeding (ml)
timeFrame: Within 5 days after study inclusion
measure: Daily gastric residual volume (ml)
timeFrame: Within 5 days after study inclusion
measure: Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)
timeFrame: 0, 72 and 120 hours after study inclusion
measure: Serum levels of citrulline (μmol/L)
timeFrame: 0, 72 and 120 hours after study inclusion
measure: Serum levels of diamine oxidase (DAO, U/L)
timeFrame: 0, 72 and 120 hours after study inclusion
measure: Serum levels of D-lactic acid (mmol/L)
timeFrame: 0, 72 and 120 hours after study inclusion
measure: Superior mesenteric artery resistance index
timeFrame: 0, 72 and 120 hours after study inclusion
measure: Intra-abdominal pressure (IAP) (mmHg)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Diarrhea
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Alimentary tract hemorrhage
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Prealbumin concentration (g/L)
timeFrame: 0, 72 and 120 hours after study inclusion
measure: Acute physiology and chronic health evaluation (APACHE) Ⅱ score
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: ICU length of stay (days)
timeFrame: Up to 4 weeks
measure: In-hospital mortality (%)
timeFrame: Up to 4 weeks
measure: Peripheral venous blood CRP concentration (mg/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood hemoglobin concentration (g/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Absolute number of white blood cells in the peripheral venous blood (number/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Absolute number of platelets in the peripheral venous blood (number/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Absolute number of lymphocytes in the peripheral venous blood (number/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Whole blood pH
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Arterial PaO2 (mmHg)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Arterial PaCO2 (mmHg)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Arterial bicarbonate (mmol/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Arterial lactic acid (mmol/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood albumin concentration (g/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood total bilirubin concentration (μmol/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood bound bilirubin concentration (μmol/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood creatinine concentration (μmol/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood ALT concentration (U/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
measure: Peripheral venous blood AST concentration (U/L)
timeFrame: 0, 24, 48, 72, 96 and 120 hours after study inclusion
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: