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Completed

NCT Number: NCT03612687

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas
  • Suspected inability to comply with trial procedures or understand consent
  • Employee at the investigational center, relative or spouse of the investigators
  • Patients incarcerated at the time of surgery
  • Females who are pregnant or breastfeeding
  • Planned use of Cell Saver during surgical procedure

Treatment and study plan

Minimally invasive hemodynamic monitoring

Device

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

Primary outcomes

  1. Incidence of intraoperative complications

    Time frame: Intraoperative period

    Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events

Secondary outcomes

  1. Extubation time

    Time frame: up to 48 hours

    Measurement of time to extubation (hours)

  2. Incidence of postoperative blood transfusions

    Time frame: up to 10 days

    Volume of blood transfused following surgical procedure (mL)

  3. Incidence of postoperative complications

    Time frame: up to 10 days

    Rate of pre-specified postoperative complications (number of patients affected)

  4. ICU length of stay

    Time frame: up to 3 days

    Intensive Care Unit (ICU) length of stay (days)

  5. Length of hospital stay

    Time frame: up to 10 days

    Time to discharge from hospital (days)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2018
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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