Evidence of Liver TransplantationNCT03013634
Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation
A study testing Dexmedetomidine and Normal saline in people with Evidence of Liver Transplantation and Myocardial Injury, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Evidence of Liver Transplantation, Myocardial Injury
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital
Who cannot join
- Pre-existing respiratory failure,renal failure,hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.24 Fukang Road,Nankai District
Tianjin, Tianjin Municipality, 300192
Wenli Yu, PhD, 86-13920098326, yzxyuwenli@163.com
About this study
The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation
Read the detailed 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.
- Being tested
- Dexmedetomidine, Normal saline
- Keywords
- dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
Normal salineDrug
Equal volume normal saline substitute for dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation. Receives: Drug: Dexmedetomidine |
| Normal saline Group | Placebo comparator | Equal volume normal saline substitute for dexmedetomidine Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative mortality
Measured: through study completion, an average of 5 weeks
The incidence of cardiac complications
Measured: from anesthesia induction to 24 hours after operation
Secondary outcomes (1)
Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence
myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein
Measured: before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenli Yu, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013634
- Sponsor's protocol ID
- TianjinFCH
- Status last verified
- Jan 2017
- First submitted
- 22 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation
- ClinicalTrials.gov ID
- NCT03013634
- Acronym / sponsor ID
- TianjinFCH
- Keywords
- dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidineDexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation. |
| Normal saline Group | Placebo comparator | Drug: Normal salineEqual volume normal saline substitute for dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital
Key exclusion criteria (1 listed)
- Pre-existing respiratory failure,renal failure,hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation. | Drug | Dexmedetomidine Group |
| Normal salineEqual volume normal saline substitute for dexmedetomidine | Drug | Normal saline Group |
Primary outcome
Peri-operative mortality
Time frame: through study completion, an average of 5 weeks
The incidence of cardiac complications
Time frame: from anesthesia induction to 24 hours after operation
1 secondary outcome
Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence
Time frame: before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal saline in people with Evidence of Liver Transplantation and Myocardial Injury, run by Tianjin First Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenli Yu, PhD (86-13920098326, yzxyuwenli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative mortality (time frame: through study completion, an average of 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.