Traditional Chinese Medicine for Complications in Critically Ill Patients

Critically Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458687
• Other study ID #: CMUH111-REC3-064
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: July 2022
• Source: China Medical University Hospital
• Contact: Yu-Chen Lee, Ph.D.
• Phone: 886-4-22052121
• Email: d5167[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients

Intervention

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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.