Autoregulation Assessment During Liver Transplantation

NCT01425385 | Completed

• 1 other identifier: NA_00051645
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Liver Failure; Liver Transplantation; Encephalopathy

Keywords

liver failure; liver transplantation

Study Arms (1)

Autoregulation monitoring

Patients will be grouped into Meld Score

Other: Near infrared spectroscopy monitoring; Other: Autoregulation monitoring

Interventions

Near infrared spectroscopy monitoring OTHER

This is an observational study without interventions

Also known as: Cerebral oximetry index and hemaglobin volume index

Autoregulation monitoring

Autoregulation monitoring OTHER

There are no interventions in this observational study

Also known as: Cerebral oximetry

Autoregulation monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years old and undergoing liver transplantation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 22644887 DERIVED

MeSH Terms

Conditions

Liver Failure; Brain Diseases

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charles W Hogue, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)