Traditional Chinese Medicine for Complications in Critically Ill Patients

Traditional Chinese Medicine for Complications in Critically Ill Patients: a Randomized Control Trial

The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill Patients
• Intervention / Treatment: Other: Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance

Detailed Description

Introduction: Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.

Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Chen Lee, Ph.D.; Phone Number: 4564 886-4-22052121; Email: d5167@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospital
    • Contact: Yu-Chen Lee, Ph.D.; Phone Number: +886-975-682-023; Email: d5167@mail.cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 20-90
• newly intensive care unit admission (<48 hours)
• Two or less inotropic medicine prescribed

Exclusion Criteria:

• Clinically unstable: receiving more than inotropic agents.
• Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Chinese herbal medicine decoction.; Acupuncture or Laser acupuncture pen treatment.; Acupoint Tuina massage.; Acupoint application of traditional Chinese herbal medicinal cake.; Nursing and health education and guidance.; Diet and health education.	Other: Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance; Chinese herbal medicine decoction: prescribed three times a day, seven days a week, and lasts for up to one weeks.; Acupuncture or Laser acupuncture pen treatment: twice a week, once for 20 minutes,up to a total of one week.; Acupoint Tuina massage: once a day for up to 20 minutes each time, for up to a week.; Acupoint application of traditional Chinese herbal medicinal cake: Apply warm navel ointment in our hospital to CV 4 (Guanyuan) point every day, and remove after getting up the next day, seven days a week for up to one week.; Nursing and health education and guidance: teach the patients and their family members the matters needing attention in daily life.; Diet and health education:give personalized Traditional Chinese Medicine diet guidance and recommendations in accordance with Traditional Chinese Medicine physique syndrome.
No Intervention: control group; Nursing and health education and guidance; Diet and health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.	For delirium use the Intensive Care Delirium Screening Checklist (ICDSC) score of:0~8. And Richmond Agitation-Sedation Scale (RASS) score of: -5~+4. For pain use the Behavioral pain scale(BPS) score of:3~12.	ICDSC、RASS、BPS record by everyday.

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Anticipated): June 20, 2023
• Study Completion (Anticipated): June 20, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine, intensive care,
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CMUH111-REC3-064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No