Liver TransplantationNCT03024840
Anaesthetic and Pediatric Living Related Liver Transplantation
A study testing Sevoflurane and Propofol in people with Liver Transplantation and Children, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation . Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Liver Transplantation, Children
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 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 4 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with end-stage liver disease Children with biliary atresia
Who cannot join
- pre-existing cerebral disease second liver transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
No.24 Fukang Road,Nankai District
Tianjin, Tianjin Municipality, 300192
About this study
Official title: The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation
To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation .
Read the detailed description
Since the 1960 s, with the successful development of liver transplantation, it has become an important method for the treatment of patients with end-stage liver disease.Biliary atresia1 is the most frequent causes of pediatric end-stage liver disease,.The morbidity of congenital biliary atresia is 1/8000-18, 0002 ,which influence the patients' overall growth and development situation. The rising of living donor liver transplantation has provide children with the chance of a timely treatment since the 1980 s, It is no doubt that pediatric liver transplantation is facing with many complications, including the most importance of neurocognitive development .Now the researches of neurological complications is less .According to statistics, the incidence of neurological complications after pediatric liver transplantation was 8% - 46% . So it is necessary to research the neurological complications and brain protection strategy .Previous studies have studied that some anaesthetic have uncertain affect on the development of children.
- Conditions
- Liver Transplantation, Children
- Being tested
- Sevoflurane, Propofol
- Keywords
- Propofol, Neurocognitive Disorders, Liver transplantation, Pediatrics, Brain Injuries
- Medical subject headings
- Neurocognitive Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane: 1%~2%
PropofolDrug
Propofol: 9-15 mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Experimental | Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery. Receives: Drug: Sevoflurane |
| propofol | Experimental | Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence
Measured: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
Measured: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Secondary outcomes (3)
Evaluation of neurocognitive disorder using Bayley Scales of Infant Development
Measured: 1 day before surgery, 7days,14 days and 21days of post-operation
Evaluation of delirium using Pediatric Anesthesia Emergence Delirium
Measured: Within 1 days after extubation
hemodynamics index
Measured: before skin incision, 0.5 hour after anhepatic,1 hour 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 posted19 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT03024840
- Sponsor's protocol ID
- 2016N0039KY
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2016
- Last updated
- 19 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 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation
- ClinicalTrials.gov ID
- NCT03024840
- Acronym / sponsor ID
- 2016N0039KY
- Conditions
- Liver Transplantation, Children
- Keywords
- Propofol, Neurocognitive Disorders, Liver transplantation, Pediatrics, Brain Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 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.
To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation .
Detailed description
Since the 1960 s, with the successful development of liver transplantation, it has become an important method for the treatment of patients with end-stage liver disease.Biliary atresia1 is the most frequent causes of pediatric end-stage liver disease,.The morbidity of congenital biliary atresia is 1/8000-18, 0002 ,which influence the patients' overall growth and development situation. The rising of living donor liver transplantation has provide children with the chance of a timely treatment since the 1980 s, It is no doubt that pediatric liver transplantation is facing with many complications, including the most importance of neurocognitive development .Now the researches of neurological complications is less .According to statistics, the incidence of neurological complications after pediatric liver transplantation was 8% - 46% . So it is necessary to research the neurological complications and brain protection strategy .Previous studies have studied that some anaesthetic have uncertain affect on the development of children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Experimental | Drug: SevofluraneSevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery. |
| propofol | Experimental | Drug: PropofolPropofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery. |
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with end-stage liver disease Children with biliary atresia
Key exclusion criteria (1 listed)
- pre-existing cerebral disease second liver transplantation
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 |
|---|---|---|
| SevofluraneSevoflurane: 1%~2% | Drug | sevoflurane |
| PropofolPropofol: 9-15 mg/kg/h | Drug | propofol |
Primary outcome
Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence
Time frame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
Time frame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
3 secondary outcomes
Evaluation of neurocognitive disorder using Bayley Scales of Infant Development
Time frame: 1 day before surgery, 7days,14 days and 21days of post-operation
Evaluation of delirium using Pediatric Anesthesia Emergence Delirium
Time frame: Within 1 days after extubation
hemodynamics index
Time frame: before skin incision, 0.5 hour after anhepatic,1 hour 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 19 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with Liver Transplantation and Children, 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 19 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence (time frame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation). 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 19 Jan 2017.