Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation

Myocardial Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013634
• Other study ID #: TianjinFCH
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2016
• Last updated: January 4, 2017
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: January 2017
• Source: Tianjin First Central Hospital
• Contact: Wenli Yu, PhD
• Phone: 86-13920098326
• Email: yzxyuwenli[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation

Description:

Liver transplantation surgery may lead to myocardial injury. Dexmedetomidine, a highly specific α2-adrenoeptor agonist, has sedative and analgesic properties without significant respiratory depression at the clinically approved dosage. Some investigations indicated that dexmedetomidine was able to protect the myocardium via improving the activity of Na+-K+-adenosine triphosphate enzyme and Ca2+-adenosine triphosphate, alleviating inflammation reaction and avoiding Ca2+ overload. However, the effect and the mechanism of dexmedetomidine on myocardial injury during liver transplantation remain unclear.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital

Exclusion Criteria:

• Pre-existing respiratory failure,renal failure,hepatic encephalopathy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Evidence of Liver Transplantation
• Myocardial Injury

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
• Normal saline
Equal volume normal saline substitute for dexmedetomidine

Locations

Country	Name	City	State
China	No.24 Fukang Road,Nankai District	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of ICU stay		through study completion, an average of 5 days	Yes
Other	length of stay	from date of admission to discharge time	through study completion, an average of 6 weeks	Yes
Primary	Peri-operative mortality		through study completion, an average of 5 weeks	Yes
Primary	The incidence of cardiac complications		from anesthesia induction to 24 hours after operation	Yes
Secondary	Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence	myohemoglobin,creatine kinase isoenzyme,cardiac troponin?,Heart-type fatty acid-binding protein	before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation	Yes