Liver TransplantationNCT03694301
Physiological Data Analysis of Patients Undergoing Anesthesia for Liver Transplantation
An observational study of Liver Transplantation, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
To record the intra-operative digital data from the standard monitoring instruments containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index) containing neurological system information captured in the patient… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Oct 2020
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have been registered or treated in the investigator's hospital as candidates for liver transplantation recipient.
Who may be able to join
- Adult patient undergoing living donor liver transplant with MELD score < 20
Who cannot join
- Vulnerable populations per institutional regulation, including under-age, history of drug abuse, HIV carrier, AIDS, aborigine, prisoner.
- Unable to communicate, for example hepatoencephalopathy, on endotracheal tube with ventilator support
- Complicated liver transplant procedure, for example domino liver donation
- Poor liver graft condition, donor have fatty liver (>15% adipose tissue by liver biopsy pathologic report)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Record and Analyze the Data of Patient Undergoing Anesthesia for Liver Transplantation From Patient Monitoring Instruments
To record the intra-operative digital data from the standard monitoring instruments containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index) containing neurological system information captured in the patient monitor, as well as the physiological data regarding anesthetic dosage, respiratory gas analysis and the standard monitoring requirement of anesthesia. All above data comes from patients undergoing liver transplantation surgery for medical reason. The investigators also record the precise time points of detail surgical stages during the surgery . Clinical data collected from these monitoring instrument will be used to gain more understanding of the complex interaction between anesthetic effect, surgical procedure, autonomic response and drug modeling. The goal is to obtain the clinical value of various features extracted from physiological data, in particular the waveform data from cardiovascular system.
Read the detailed description
Liver transplantation surgery brings huge influences on the human body of the recipient intra-operatively. Anesthesiologists facing challenges from hemodynamic function, neurological function, coagulation function use monitoring instruments as a guide to make timely anesthetic judgement. As good as those well designed monitoring instruments displaying vital information, the investigators would like to explore any possible hidden data features which is not perceivable with naked eye.
In this prospective observational study, the investigators will enroll 40 patients undergoing liver transplantation surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including cardiovascular system information (electrocardiography, photo-plethysmography , blood pressure, cardiac output, and any additional monitoring items clinically required), parameters derived from pulse contour analysis (cardiac output, stroke volume, stroke volume variation... etc.), neurological system information (Bispectral index, Entropy, Surgical Plethysmography Index, cerebral oximeter ) and the respiratory gas monitoring (gas analyzer, respiratory waveform). All above data are provided by monitoring instruments routinely used for liver transplantation, including CARESCAPE Monitor B850 (GE Healthcare) FloTrac system (Edwards Lifesciences).
The surgical steps will be noted with precise time stamps to establish temporal relationships. Registered events including anesthetic induction, intubation, disinfection, dissection stage, anhepatic stage , inferior vena cava clamping, reperfusion, neohepatic stage and other important surgical steps. The recording is ended before the end of monitoring in the operating room. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the temporal effect and relationship. Methods including signal processing, modeling, classification and non-parametric spectral estimation will be used.
- Conditions
- Liver Transplantation
- Keywords
- Monitoring, Intraoperative, Pulse Wave Analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between SPI value and heart rate variability at predefined surgical step
Surgical Pleth Index (SPI) is a newly developed pain monitor derived from analysis of pulse oximetry signal. Such analysis is based on heart rate variability for autonomic nervous system activity. However the accuracy of SPI is questioned for interference of vasculopathy upon pulse oximeter signal quality. For liver transplant, there are three stages as followed: dissection phase, anhepatic phase and neohepatic phase. Liver plays an important role in renin-angiotensin-aldosterone system which affects the vessel tone. Therefore, the investigators will explore the correlation of heart rate variability calculated from ECG QRS complex and SPI at these three different stages in liver transplant. The Spearman rank correlation > 0.7 and the prediction probability vale > 0.7 are positive outcome result.
Measured: During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.
Correlation between Arterial waveform and Flotrac(TM) cardiac output analysis
Liver plays an important role in renin-angiotensin-aldosterone system which affects vessel tone. At anhepatic phase in liver transplant, it was noticed that the reflected wave in arterial waveform disappears but the forward waveform remains. The investigators hypothesize that this is caused by the inability to transform angiotensinogen without liver. Flotrac by Edward lifescience is a device to calculate cardiac output and stroke volume variation from arterial waveform. The investigators will explore the correlation of Flotrac cardiac output with arterial waveform in anhepatic phase. The arterial waveform analysis includes area under arterial waveform, the slope for forward wave and pulse pressure. Also high dimensional method including diffusion map and locally linear embedding will be used to transform the whole waveform into more meaningful quantitative indices. The Spearman rank correlation > 0.7 and the prediction probability vale > 0.7 are positive outcome result.
Measured: During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.
Secondary outcomes (1)
Correlation between waveform analysis, graft and patient survival
Liver plays an important role in renin-angiotensin-aldosterone system which affects vessel tone. At anhepatic phase in liver transplant, it was noticed that the reflected wave in arterial waveform disappears but the forward waveform remains. The investigators hypothesize that this is caused by unabling to transform angiotensinogen without liver. The investigators hypothesized that the reflected wave in arterial waveform could represent graft function. Therefore the investigator will analyze reflected waveform after reperfusion and record patient outcome as 30-day mortality, ventilator use, ICU stay and kidney injury. The Spearman rank correlation > 0.6 is positive outcome result.
Measured: For first week after operation, data will be recorded daily including INR, blood transfusion, serum creatinine and PaO2/Fio2. Kidney and lung injury will be specified. Also the investigators will record days for ICU stay and ventilator use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Chien-Kun Ting, Dr., Study chair, Department of Anesthesiology, Taipei Veterans General Hospital, TaiwanShen-Chih Wang, Dr., Principal investigator, Department of Anesthesiology, Taipei Veterans General Hospital, TaiwanHsin-Lin Tsai, Dr., Principal investigator, Department of Surgery, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694301
- Sponsor's protocol ID
- V107C-209L
- Status last verified
- Oct 2018
- First submitted
- 18 Sep 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome will be made available at Dataverse. (https://dataverse.harvard.edu/)
Publications
Wang SC, Lin HT, Chang KY, Mandell MS, Ting CK, Chu YC, Loong CC, Chan KH, Tsou MY. Use of higher thromboelastogram transfusion values is not associated with greater blood loss in liver transplant surgery. Liver Transpl. 2012 Oct;18(10):1254-8. doi: 10.1002/lt.23494.
PubMed 22730210Wang SC, Teng WN, Chang KY, Susan Mandell M, Ting CK, Chu YC, Loong CC, Chan KH, Tsou MY. Fluid management guided by stroke volume variation failed to decrease the incidence of acute kidney injury, 30-day mortality, and 1-year survival in living donor liver transplant recipients. J Chin Med Assoc. 2012 Dec;75(12):654-9. doi: 10.1016/j.jcma.2012.08.007. Epub 2012 Nov 17.
PubMed 23245482
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Record and Analyze the Data of Patient Undergoing Anesthesia for Liver Transplantation From Patient Monitoring Instruments
- ClinicalTrials.gov ID
- NCT03694301
- Acronym / sponsor ID
- V107C-209L
- Conditions
- Liver Transplantation
- Keywords
- Monitoring, Intraoperative, Pulse Wave Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Duke University
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 3 Oct 2018 (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.
To record the intra-operative digital data from the standard monitoring instruments containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index) containing neurological system information captured in the patient monitor, as well as the physiological data regarding anesthetic dosage, respiratory gas analysis and the standard monitoring requirement of anesthesia. All above data comes from patients undergoing liver transplantation surgery for medical reason. The investigators also record the precise time points of detail surgical stages during the surgery . Clinical data collected from these monitoring instrument will be used to gain more understanding of the complex interaction between anesthetic effect, surgical procedure, autonomic response and drug modeling. The goal is to obtain the clinical value of various features extracted from physiological data, in particular the waveform data from cardiovascular system.
Detailed description
Liver transplantation surgery brings huge influences on the human body of the recipient intra-operatively. Anesthesiologists facing challenges from hemodynamic function, neurological function, coagulation function use monitoring instruments as a guide to make timely anesthetic judgement. As good as those well designed monitoring instruments displaying vital information, the investigators would like to explore any possible hidden data features which is not perceivable with naked eye.
In this prospective observational study, the investigators will enroll 40 patients undergoing liver transplantation surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including cardiovascular system information (electrocardiography, photo-plethysmography , blood pressure, cardiac output, and any additional monitoring items clinically required), parameters derived from pulse contour analysis (cardiac output, stroke volume, stroke volume variation... etc.), neurological system information (Bispectral index, Entropy, Surgical Plethysmography Index, cerebral oximeter ) and the respiratory gas monitoring (gas analyzer, respiratory waveform). All above data are provided by monitoring instruments routinely used for liver transplantation, including CARESCAPE Monitor B850 (GE Healthcare) FloTrac system (Edwards Lifesciences).
The surgical steps will be noted with precise time stamps to establish temporal relationships. Registered events including anesthetic induction, intubation, disinfection, dissection stage, anhepatic stage , inferior vena cava clamping, reperfusion, neohepatic stage and other important surgical steps. The recording is ended before the end of monitoring in the operating room. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the temporal effect and relationship. Methods including signal processing, modeling, classification and non-parametric spectral estimation will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have been registered or treated in the investigator's hospital as candidates for liver transplantation recipient.
Key inclusion criteria (1 listed)
- Adult patient undergoing living donor liver transplant with MELD score < 20
Key exclusion criteria (4 listed)
- Vulnerable populations per institutional regulation, including under-age, history of drug abuse, HIV carrier, AIDS, aborigine, prisoner.
- Unable to communicate, for example hepatoencephalopathy, on endotracheal tube with ventilator support
- Complicated liver transplant procedure, for example domino liver donation
- Poor liver graft condition, donor have fatty liver (>15% adipose tissue by liver biopsy pathologic report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between SPI value and heart rate variability at predefined surgical step
Time frame: During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.
Surgical Pleth Index (SPI) is a newly developed pain monitor derived from analysis of pulse oximetry signal. Such analysis is based on heart rate variability for autonomic nervous system activity. However the accuracy of SPI is questioned for interference of vasculopathy upon pulse oximeter signal quality. For liver transplant, there are three stages as followed: dissection phase, anhepatic phase and neohepatic phase. Liver plays an important role in renin-angiotensin-aldosterone system which affects the vessel tone. Therefore, the investigators will explore the correlation of heart rate variability calculated from ECG QRS complex and SPI at these three different stages in liver transplant. The Spearman rank correlation > 0.7 and the prediction probability vale > 0.7 are positive outcome result.
Correlation between Arterial waveform and Flotrac(TM) cardiac output analysis
Time frame: During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.
Liver plays an important role in renin-angiotensin-aldosterone system which affects vessel tone. At anhepatic phase in liver transplant, it was noticed that the reflected wave in arterial waveform disappears but the forward waveform remains. The investigators hypothesize that this is caused by the inability to transform angiotensinogen without liver. Flotrac by Edward lifescience is a device to calculate cardiac output and stroke volume variation from arterial waveform. The investigators will explore the correlation of Flotrac cardiac output with arterial waveform in anhepatic phase. The arterial waveform analysis includes area under arterial waveform, the slope for forward wave and pulse pressure. Also high dimensional method including diffusion map and locally linear embedding will be used to transform the whole waveform into more meaningful quantitative indices. The Spearman rank correlation > 0.7 and the prediction probability vale > 0.7 are positive outcome result.
1 secondary outcome
Correlation between waveform analysis, graft and patient survival
Time frame: For first week after operation, data will be recorded daily including INR, blood transfusion, serum creatinine and PaO2/Fio2. Kidney and lung injury will be specified. Also the investigators will record days for ICU stay and ventilator use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Background: PubMed 22730210Wang SC, Lin HT, Chang KY, Mandell MS, Ting CK, Chu YC, Loong CC, Chan KH, Tsou MY. Use of higher thromboelastogram transfusion values is not associated with greater blood loss in liver transplant surgery. Liver Transpl. 2012 Oct;18(10):1254-8. doi: 10.1002/lt.23494.
- Background: PubMed 23245482Wang SC, Teng WN, Chang KY, Susan Mandell M, Ting CK, Chu YC, Loong CC, Chan KH, Tsou MY. Fluid management guided by stroke volume variation failed to decrease the incidence of acute kidney injury, 30-day mortality, and 1-year survival in living donor liver transplant recipients. J Chin Med Assoc. 2012 Dec;75(12):654-9. doi: 10.1016/j.jcma.2012.08.007. Epub 2012 Nov 17.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome will be made available at Dataverse. (https://dataverse.harvard.edu/)
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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.
Chien-Kun Ting, Dr. study chair
Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
Shen-Chih Wang, Dr. principal investigator
Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
Hsin-Lin Tsai, Dr. principal investigator
Department of Surgery, Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Taipei Veterans General Hospital, Taiwan.
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 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 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Kuang-Yi Chang, Dr. (+886-938593159, sufentanil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between SPI value and heart rate variability at predefined surgical step (time frame: During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.). 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?
On the ClinicalTrials.gov record for NCT03694301, which also lists 2 linked publications.
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 4 Oct 2018.