Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

Completed

• Conditions: Cancer
• Interventions: Device: Minimally invasive hemodynamic monitoring

• Registration Number: NCT03612687
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-22
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic Liver Surgery	Minimally invasive hemodynamic monitoring	Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring
Laparoscopic Pancreas Surgery	Minimally invasive hemodynamic monitoring	Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring
Open Liver Surgery	Minimally invasive hemodynamic monitoring	Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring
Open Pancreas Surgery	Minimally invasive hemodynamic monitoring	Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative complications	Intraoperative period	Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events

Secondary Outcome Measures

Name	Time	Method
Extubation time	up to 48 hours	Measurement of time to extubation (hours)
Length of hospital stay	up to 10 days	Time to discharge from hospital (days)
Incidence of postoperative blood transfusions	up to 10 days	Volume of blood transfused following surgical procedure (mL)
Incidence of postoperative complications	up to 10 days	Rate of pre-specified postoperative complications (number of patients affected)
ICU length of stay	up to 3 days	Intensive Care Unit (ICU) length of stay (days)

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States