Liver Transplant; ComplicationsPhase 2NCT03102359
Brain Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation
A Phase 2 study testing Dexmedetomidine and Cooling Helmet in people with Liver Transplant; Complications, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Dexmedetomidine and Cooling Helmet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2017to 31 Dec 2019
- Phase
- Phase 2
- 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
- Scheduled for OLT, selected from the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.
- Sign the informed consent
Who cannot join
- The patients with a history of neurological or psychiatric disorders which impair cognitive processes, including previously established de-mentia, stroke, schizophrenia and depression were excluded from the study.
- Patients diagnosed with hepatic encephalopathy or had a low Mini-Mental State Examination (MMSE) score (below 24) preoperatively.
- With concurrent diseases such as renal insufficiency, diabetes mellitus were also excluded.
- Patients were excluded if severe reperfusion syn-drome (mean arterial pressure below 60mmHg sustained over 15minutes) occurred perioperatively.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430040
Lei Li, postgraduate, 18627752156, 535413900@qq.com
About this study
Official title: Cerebral Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation
The investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation.
- Conditions
- Liver Transplant; Complications
- Being tested
- Dexmedetomidine, Cooling Helmet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery
Cooling HelmetDevice
Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group
| Study group | Role | What they receive |
|---|---|---|
| Selective Head Cooling | Experimental | Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery. Receives: Device: Cooling Helmet |
| Dexmedetomidine | Experimental | Giving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery. Receives: Drug: Dexmedetomidine |
| Selective Head Cooling and Dexmedetomidine | Experimental | Using selective head cooling combined with dexmedetomidine as described before Receives: Drug: Dexmedetomidine; Device: Cooling Helmet |
| Control | No intervention | No intervention in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative minimal hepatic encephalopathy (MHE)
Using PSE-Syndrom-Test
Measured: 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start5 Apr 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huawei He, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102359
- Sponsor's protocol ID
- TJ-IRB20170201
- Status last verified
- May 2019
- First submitted
- 24 Mar 2017
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT03102359
- Acronym / sponsor ID
- TJ-IRB20170201
- Conditions
- Liver Transplant; Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Apr 2017 (actual)
- 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 investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Selective Head Cooling | Experimental | Device: Cooling HelmetParticipants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery. |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineGiving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery. |
| Selective Head Cooling and Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Device: Cooling HelmetUsing selective head cooling combined with dexmedetomidine as described before |
| Control | No intervention | –No intervention in this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for OLT, selected from the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.
- Sign the informed consent
Key exclusion criteria (4 listed)
- The patients with a history of neurological or psychiatric disorders which impair cognitive processes, including previously established de-mentia, stroke, schizophrenia and depression were excluded from the study.
- Patients diagnosed with hepatic encephalopathy or had a low Mini-Mental State Examination (MMSE) score (below 24) preoperatively.
- With concurrent diseases such as renal insufficiency, diabetes mellitus were also excluded.
- Patients were excluded if severe reperfusion syn-drome (mean arterial pressure below 60mmHg sustained over 15minutes) occurred perioperatively.
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 |
|---|---|---|
| DexmedetomidineUsing dexmedetomidine at anesthesia induction and maintain until the end of the surgery | Drug | Dexmedetomidine, Selective Head Cooling and Dexmedetomidine |
| Cooling HelmetUsing cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group | Device | Selective Head Cooling, Selective Head Cooling and Dexmedetomidine |
Primary outcome
Postoperative minimal hepatic encephalopathy (MHE)
Time frame: 14 days after surgery
Using PSE-Syndrom-Test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Dexmedetomidine and Cooling Helmet in people with Liver Transplant; Complications, run by Huazhong University of Science and Technology 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 2 inclusion and 4 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 29 May 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ailin Luo, doctorate (13507122565, alluo@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative minimal hepatic encephalopathy (MHE) (time frame: 14 days after surgery). 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 29 May 2019.