Clinical trial NCT03612687: Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery
Official title: Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Hemodynamic Monitoring
Perioperative Fluid Management
Hepatobiliary and Pancreas Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The procedures will be divided by organ systems, liver and pancreas, and by method of surgery, laparoscopic versus open. Five patients will be chosen for each group for a total of 20 patients enrolled. The following procedures will be included in the study: liver resection (\>2 segments), distal pancreatectomy and splenectomy, and pancreaticoduodenectomy, including robotic procedures.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of intraoperative complications
timeFrame: Intraoperative period
Secondary outcomes:
measure: Extubation time
timeFrame: up to 48 hours
measure: Incidence of postoperative blood transfusions
timeFrame: up to 10 days
measure: Incidence of postoperative complications
timeFrame: up to 10 days
measure: ICU length of stay
timeFrame: up to 3 days
measure: Length of hospital stay
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ryan Swan, MD
role: PRINCIPAL_INVESTIGATOR
References: