Clinical Trial Record

Return to Clinical Trials

Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery


2014-05


2014-09


2014-11


20

Study Overview

Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.

Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.

  • Cancer
  • DEVICE: Minimally invasive hemodynamic monitoring
  • 03-14-03E

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2014-05-22  

N/A  

2022-04-20  

2018-07-27  

N/A  

2022-04-27  

2018-08-02  

N/A  

2018-07  

Study Plan

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

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Laparoscopic Liver Surgery

Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring

DEVICE: Minimally invasive hemodynamic monitoring

  • Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
: Laparoscopic Pancreas Surgery

Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring

DEVICE: Minimally invasive hemodynamic monitoring

  • Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
: Open Liver Surgery

Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring

DEVICE: Minimally invasive hemodynamic monitoring

  • Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
: Open Pancreas Surgery

Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring

DEVICE: Minimally invasive hemodynamic monitoring

  • Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of intraoperative complicationsCardiocirculatory, respiratory, neurological, renal, infectious and major bleeding eventsIntraoperative period
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Extubation timeMeasurement of time to extubation (hours)up to 48 hours
Incidence of postoperative blood transfusionsVolume of blood transfused following surgical procedure (mL)up to 10 days
Incidence of postoperative complicationsRate of pre-specified postoperative complications (number of patients affected)up to 10 days
ICU length of stayIntensive Care Unit (ICU) length of stay (days)up to 3 days
Length of hospital stayTime to discharge from hospital (days)up to 10 days

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    Inclusion Criteria:
    1. Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy.
    Exclusion Criteria:
    1. Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas 2. Suspected inability to comply with trial procedures or understand consent 3. Employee at the investigational center, relative or spouse of the investigators 4. Patients incarcerated at the time of surgery 5. Females who are pregnant or breastfeeding 6. Planned use of Cell Saver during surgical procedure

Collaborators and Investigators

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


    • PRINCIPAL_INVESTIGATOR: Ryan Swan, MD, Wake Forest University Health Sciences

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available