Autoregulation Assessment During Liver Transplantation

August 17, 2017 updated by: Johns Hopkins University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. To assess whether patients undergoing liver transplantation have impaired cerebral blood flow autoregulation.
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

-Age > 18 years old and undergoing liver transplantation.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Autoregulation monitoring
Patients will be grouped into Meld Score
Other: Near infrared spectroscopy monitoring
This is an observational study without interventions
Other Names:
  • Cerebral oximetry index and hemaglobin volume index
Other: Autoregulation monitoring
There are no interventions in this observational study
Other Names:
  • Cerebral oximetry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charles W Hogue, MD, Johns Hopkins University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NA_00051645

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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