Liver FailureNCT01425385
Autoregulation Assessment During Liver Transplantation
An observational study of Liver Failure and Liver Transplantation, run by Johns Hopkins University at 1 site in United States.
Trial summary
Patients with liver failure undergoing liver transplantation often have clinical or sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may lead to abnormal regulation of blood flow to the brain (cerebral autoregulation) complicating patient management during and after general… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Liver Transplantation, Encephalopathy
- What is being tested?
- Near infrared spectroscopy monitoring and Autoregulation monitoring
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this pilot study we will enroll 20 patients undergoing orthotopic liver transplantation at The Johns Hopkins Hospital. Patients will receive standard care during the procedure. Study related procedures are non-invasive and observational. There will be no interventions based on the results of the study data. The study will include only the immediate operative period. The patients will have transcranial Doppler monitoring and near infrared spectroscopy monitoring during surgery beginning before anesthesia induction and continued until the end of surgery.
Who may be able to join
- -Age > 18 years old and undergoing liver transplantation.
Who cannot join
- Clinical instability as judged by the attending physicians whereby autoregulation monitoring may interfere with clinical care.
- Women of child bearing potential require a negative urine human chorionic gonadotropin (HCG) test to be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Non-Invasive Assessment of Cerebral Blood Flow Autoregulation in Patients Undergoing Liver Transplantation
Patients with liver failure undergoing liver transplantation often have clinical or sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may lead to abnormal regulation of blood flow to the brain (cerebral autoregulation) complicating patient management during and after general anesthesia. The current methods for monitoring for elevated intracranial pressure are invasive and, thus, limited to severe encephalopathy. In this study the investigators will evaluate the potential utility of monitoring cerebral blood flow (CBF) autoregulation non-invasively using near infra-red spectroscopy in patients undergoing liver transplantation.
Read the detailed description
Hepatic encephalopathy complicating chronic liver failure in patients undergoing liver transplantation increases the risk for adverse outcomes including mortality. Even mild hepatic encephalopathy may not be recognized clinically without specific testing but can be associated with impaired functional status and reduced quality of life before liver transplantation. The changes that can be seen in chronic liver failure, (cerebral edema and increased intracranial pressure) can adversely affect cerebral blood flow autoregulation that may predispose to brain injury during the multiple hemodynamic perturbations that occur during and after liver transplantation. Currently, invasive monitoring with an intracranial "bolt" is the only method to aggressively manage patients with elevated intracranial pressure from acute liver failure and hepatic encephalopathy. The placement of an intracranial pressure catheter in patient with liver failure is associated with a risk of brain hemorrhage due the presence of a coagulopathy. Further, the risk of this type of monitoring outweighs the benefits in the patients with milder or subclinical forms of hepatic encephalopathy. In this pilot study of 20 patients undergoing liver transplantation the investigators will evaluate the feasibility of non-invasive monitoring of CBF autoregulation and assess whether autoregulation is impaired in this group of patients. The investigators hypothesize that cerebral blood flow autoregulation is impaired in patients undergoing liver transplantation based on severity of liver disease. In this situation, improved patient monitoring would allow clinicians to maintain arterial blood pressure above an individual's lower limit of cerebral blood flow autoregulation that might prevent devastating brain injury during and after surgery. Cerebral blood flow autoregulation can be continuously monitored by evaluating the correlation coefficient between cerebral blood flow velocity measured with transcranial Doppler and arterial blood pressure. The investigators have developed a novel method of autoregulation monitoring using near infrared spectroscopy that allows continuous monitoring of autoregulation with the cerebral oximetry index and the hemoglobin volume index(, a moving linear correlation coefficient between cortical tissue oxygen saturation and hemoglobin level with arterial blood pressure, respectively. The latter approach is more practical and would allow widespread autoregulation monitoring in diverse clinical settings. A secondary hypothesis of this study is that near infrared spectroscopy-based monitoring of CBF autoregulation will provide an accurate assessment of the limits of autoregulation compared with the more clinically challenging transcranial Doppler methods .
Specific Aims:
- To assess whether patients undergoing liver transplantation have impaired cerebral blood flow autoregulation.
- To evaluate whether non-invasive monitoring of cerebral blood flow autoregulation with cerebral oximetry index and hemoglobin volume index can identify the lower limit of autoregulation within 10 mmHg compared with that measured with transcranial Doppler.
- Conditions
- Liver Failure, Liver Transplantation, Encephalopathy
- Being tested
- Near infrared spectroscopy monitoring, Autoregulation monitoring
- Keywords
- liver failure, liver transplantation
- Medical subject headings
- Liver Failure, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy monitoringOther
Also called Cerebral oximetry index and hemaglobin volume index
This is an observational study without interventions
Autoregulation monitoringOther
Also called Cerebral oximetry
There are no interventions in this observational study
| Study group | Role | What they receive |
|---|---|---|
| Autoregulation monitoring | Patients will be grouped into Meld Score Receives: Other: Near infrared spectroscopy monitoring; Other: Autoregulation monitoring |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles W Hogue, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425385
- Sponsor's protocol ID
- NA_00051645
- Status last verified
- Aug 2017
- First submitted
- 26 Aug 2011
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zheng Y, Villamayor AJ, Merritt W, Pustavoitau A, Latif A, Bhambhani R, Frank S, Gurakar A, Singer A, Cameron A, Stevens RD, Hogue CW. Continuous cerebral blood flow autoregulation monitoring in patients undergoing liver transplantation. Neurocrit Care. 2012 Aug;17(1):77-84. doi: 10.1007/s12028-012-9721-1.
PubMed 22644887
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Assessment of Cerebral Blood Flow Autoregulation in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT01425385
- Acronym / sponsor ID
- NA_00051645
- Conditions
- Liver Failure, Liver Transplantation, Encephalopathy
- Keywords
- liver failure, liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2011 (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.
Patients with liver failure undergoing liver transplantation often have clinical or sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may lead to abnormal regulation of blood flow to the brain (cerebral autoregulation) complicating patient management during and after general anesthesia. The current methods for monitoring for elevated intracranial pressure are invasive and, thus, limited to severe encephalopathy. In this study the investigators will evaluate the potential utility of monitoring cerebral blood flow (CBF) autoregulation non-invasively using near infra-red spectroscopy in patients undergoing liver transplantation.
Detailed description
Hepatic encephalopathy complicating chronic liver failure in patients undergoing liver transplantation increases the risk for adverse outcomes including mortality. Even mild hepatic encephalopathy may not be recognized clinically without specific testing but can be associated with impaired functional status and reduced quality of life before liver transplantation. The changes that can be seen in chronic liver failure, (cerebral edema and increased intracranial pressure) can adversely affect cerebral blood flow autoregulation that may predispose to brain injury during the multiple hemodynamic perturbations that occur during and after liver transplantation. Currently, invasive monitoring with an intracranial "bolt" is the only method to aggressively manage patients with elevated intracranial pressure from acute liver failure and hepatic encephalopathy. The placement of an intracranial pressure catheter in patient with liver failure is associated with a risk of brain hemorrhage due the presence of a coagulopathy. Further, the risk of this type of monitoring outweighs the benefits in the patients with milder or subclinical forms of hepatic encephalopathy. In this pilot study of 20 patients undergoing liver transplantation the investigators will evaluate the feasibility of non-invasive monitoring of CBF autoregulation and assess whether autoregulation is impaired in this group of patients. The investigators hypothesize that cerebral blood flow autoregulation is impaired in patients undergoing liver transplantation based on severity of liver disease. In this situation, improved patient monitoring would allow clinicians to maintain arterial blood pressure above an individual's lower limit of cerebral blood flow autoregulation that might prevent devastating brain injury during and after surgery. Cerebral blood flow autoregulation can be continuously monitored by evaluating the correlation coefficient between cerebral blood flow velocity measured with transcranial Doppler and arterial blood pressure. The investigators have developed a novel method of autoregulation monitoring using near infrared spectroscopy that allows continuous monitoring of autoregulation with the cerebral oximetry index and the hemoglobin volume index(, a moving linear correlation coefficient between cortical tissue oxygen saturation and hemoglobin level with arterial blood pressure, respectively. The latter approach is more practical and would allow widespread autoregulation monitoring in diverse clinical settings. A secondary hypothesis of this study is that near infrared spectroscopy-based monitoring of CBF autoregulation will provide an accurate assessment of the limits of autoregulation compared with the more clinically challenging transcranial Doppler methods .
Specific Aims:
- To assess whether patients undergoing liver transplantation have impaired cerebral blood flow autoregulation.
- To evaluate whether non-invasive monitoring of cerebral blood flow autoregulation with cerebral oximetry index and hemoglobin volume index can identify the lower limit of autoregulation within 10 mmHg compared with that measured with transcranial Doppler.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoregulation monitoring | – | Other: Near infrared spectroscopy monitoring, Other: Autoregulation monitoringPatients will be grouped into Meld Score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this pilot study we will enroll 20 patients undergoing orthotopic liver transplantation at The Johns Hopkins Hospital. Patients will receive standard care during the procedure. Study related procedures are non-invasive and observational. There will be no interventions based on the results of the study data. The study will include only the immediate operative period. The patients will have transcranial Doppler monitoring and near infrared spectroscopy monitoring during surgery beginning before anesthesia induction and continued until the end of surgery.
Key inclusion criteria (1 listed)
- -Age > 18 years old and undergoing liver transplantation.
Key exclusion criteria (2 listed)
- Clinical instability as judged by the attending physicians whereby autoregulation monitoring may interfere with clinical care.
- Women of child bearing potential require a negative urine human chorionic gonadotropin (HCG) test to be enrolled.
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 |
|---|---|---|
| Near infrared spectroscopy monitoringAlso: Cerebral oximetry index and hemaglobin volume indexThis is an observational study without interventions | Other | Autoregulation monitoring |
| Autoregulation monitoringAlso: Cerebral oximetryThere are no interventions in this observational study | Other | Autoregulation monitoring |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 22644887Zheng Y, Villamayor AJ, Merritt W, Pustavoitau A, Latif A, Bhambhani R, Frank S, Gurakar A, Singer A, Cameron A, Stevens RD, Hogue CW. Continuous cerebral blood flow autoregulation monitoring in patients undergoing liver transplantation. Neurocrit Care. 2012 Aug;17(1):77-84. doi: 10.1007/s12028-012-9721-1.
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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.
Charles W Hogue, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure and Liver Transplantation, run by Johns Hopkins University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 22 Aug 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425385, which also lists 1 linked publication.
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 22 Aug 2017.